Karl Storz Endoscopy-America, Inc.
Auburn, MA, US
KARL STORZ ENDOSCOPY-AMERICA, INC. appears in FDA device records in Auburn, MA. FDA records list 402 510(k) clearances between and , 46 PMA records and 2 registered establishments. As of , FDA records show 90 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Karl Storz Endoscopy-America, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Karl Storz Endoscopy510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 402FDA records hold 402 510(k) clearances for Karl Storz Endoscopy-America, Inc. between 1980 and 2026. The busiest year on record is 1995, with 99. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1987 | 5 |
| 1988 | 3 |
| 1989 | 2 |
| 1991 | 1 |
| 1993 | 4 |
| 1994 | 49 |
| 1995 | 99 |
| 1996 | 36 |
| 1997 | 14 |
| 1998 | 18 |
| 1999 | 17 |
| 2000 | 13 |
| 2001 | 12 |
| 2002 | 11 |
| 2003 | 7 |
| 2004 | 4 |
| 2005 | 6 |
| 2006 | 3 |
| 2007 | 11 |
| 2008 | 4 |
| 2009 | 5 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 5 |
| 2013 | 4 |
| 2014 | 4 |
| 2015 | 3 |
| 2016 | 5 |
| 2017 | 8 |
| 2018 | 4 |
| 2019 | 5 |
| 2020 | 9 |
| 2021 | 8 |
| 2022 | 5 |
| 2023 | 5 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and Accessories | EQN | Substantially Equivalent | |
| K240506 | KARL STORZ Holders | OCV | Substantially Equivalent | |
| K223885 | HOPKINS Telescopes | HIH | Substantially Equivalent | |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- | GCJ | Substantially Equivalent | |
| K223520 | UNIDRIVE SIII System | HIH | Substantially Equivalent | |
| K223923 | HOPKINS Telescopes | GCJ | Substantially Equivalent | |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | FJL | Substantially Equivalent | |
| K221004 | HOPKINS Telescopes | GCJ | Substantially Equivalent | |
| K222504 | H1 | GCJ | Substantially Equivalent | |
| K213194 | HD Mediastinoscope | EWY | Substantially Equivalent | |
| K221174 | Telepack + | FET | Substantially Equivalent | |
| K212458 | Flexible Video-Uretero-Renoscope SSU System | FGB | Substantially Equivalent | |
| K212656 | Flexible Intubation Video Endoscope – Sterile (FIVE-S) | EOQ | Substantially Equivalent | |
| K212695 | KARL STORZ ICG Imaging System | OWN | Substantially Equivalent | |
| K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | FAJ | Substantially Equivalent | |
| K203198 | KARL STORZ Metal Sterilization Trays | KCT | Substantially Equivalent | |
| K202272 | HD Mediastinoscope | EWY | Substantially Equivalent | |
| K203572 | Karl Storz Radel Sterilization Trays | KCT | Substantially Equivalent | |
| K201001 | Modulith SLX-F2 | LNS | Substantially Equivalent | |
| K201945 | KARL STORZ UDEL Sterilization Trays | KCT | Substantially Equivalent | |
| K200965 | XR-MX/1000 | JAA | Substantially Equivalent | |
| K202925 | KARL STORZ ICG Imaging System | OWN | Substantially Equivalent | |
| K201526 | TIPCAM1 Rubina Video Endoscope System | GCJ | Substantially Equivalent | |
| K202957 | Flexible Video Cysto-Urethroscope (C-view) | FAJ | Substantially Equivalent | |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece | ERL | Substantially Equivalent | |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | FET | Substantially Equivalent | |
| K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head | OWN | Substantially Equivalent | |
| K200740 | HD Video Rhino Laryngoscope | EOB | Substantially Equivalent | |
| K201096 | CO2mbiLED | FCX | Substantially Equivalent | |
| K193235 | Telepack + | FET | Substantially Equivalent | |
| K191357 | Flexible HD Cysto-Urethroscope System | FAJ | Substantially Equivalent | |
| K182723 | Flexible HD Cysto-Urethroscope System | FAJ | Substantially Equivalent | |
| K182186 | CMOS Video-Rhino-Laryngoscope System | EOB | Substantially Equivalent | |
| K183264 | Flex-THOR scope | GCJ | Substantially Equivalent | |
| K182696 | Telepack X LED | FET | Substantially Equivalent | |
| K180977 | KARL STORZ New Generation Trocars | GCJ | Substantially Equivalent | |
| K180146 | KARL STORZ ICG Imaging System | GWG | Substantially Equivalent | |
| K171402 | KARL STORZ Slim Nasopharyngolaryngoscope | EOB | Substantially Equivalent | |
| K171717 | AUTOCON III 400 | GEI | Substantially Equivalent | |
| K162992 | Karl Storz UROMAT E.A.S.I. | LJH | Substantially Equivalent | |
| K171238 | KARL STORZ ICG Imaging System | OWN | Substantially Equivalent | |
| K170462 | KARL STORZ ShuntScope | GWG | Substantially Equivalent | |
| K162880 | TIPCAM 1S 3D System | GWG | Substantially Equivalent | |
| K162410 | TIPCAM 1S 3D System | EOB | Substantially Equivalent | |
| K161554 | ENDOFLATOR 40, ENDOFLATOR 50 | HIF | Substantially Equivalent | |
| K162882 | KARL STORZ ICG Imaging System | OWN | Substantially Equivalent | |
| K161555 | KARL STORZ NAV1 Electromagnetic Navigation System | PGW | Substantially Equivalent | |
| K161112 | KARL STORZ Flexible Video-Neuro-Endoscope System | GWG | Substantially Equivalent | |
| K152583 | KARL STORZ Endoscopic ICG Imaging System | OWN | Substantially Equivalent | |
| K160044 | Image1 SPIES System | FET | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2020550 | 2020550 | KARL STORZ ENDOSCOPY-AMERICA, INC. | 28 Millbury Street, Auburn, MA 01501 US | 2026 | and 197 more, listed in full below |
| 3010202439 | 3007475226 | Karl Storz Endoscopy-America, Inc. | 2151 E. Grand Avenue, El Segundo, CA 90245 US | 2026 | and 210 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)
- FAXBougie, Urological
- EOQBronchoscope (Flexible Or Rigid)
- FCYBulb, Inflation, For Endoscope
- EQJBur, Ear, Nose And Throat
- FBMCannula And Trocar, Suprapubic, Non-Disposable
- BSYCatheters, Suction, Tracheobronchial
- FBNCholedochoscope And Accessories, Flexible/Rigid
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- DXCClamp, Vascular
- FDFColonoscope And Accessories, Flexible/Rigid
- FAJCystoscope And Accessories, Flexible/Rigid
- FBOCystourethroscope
- EZNDilator, Catheter, Ureteral
- FAHDilator, Urethral, Mechanical
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- FASElectrode, Electrosurgical, Active, Urological
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- EOXEsophagoscope (Flexible Or Rigid)
- FCLForceps, Biopsy, Non-Electric
- BWBForceps, Tube Introduction
- DZNInstruments, Dental Hand
- DWSInstruments, Surgical, Cardiovascular
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- EMFKnife, Surgical
- EQNLaryngoscope, Nasopharyngoscope
- CALLaryngoscope, Non-Rigid
- CCWLaryngoscope, Rigid
- EQLLaryngostroboscope
- FCWLight Source, Fiberoptic, Routine
- FCRLight Source, Photographic, Fiberoptic
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral
- EBALight, Surgical Headlight
- BSJMask, Gas, Anesthetic
- EWYMediastinoscope, Surgical
- EPTMicroscope, Surgical
- EOBNasopharyngoscope (Flexible Or Rigid)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- ERAOtoscope
- ETBProsthesis, Partial Ossicular Replacement
- BTAPump, Portable, Aspiration (Manual Or Powered)
- ETAReplacement, Ossicular Prosthesis, Total
- FDCResectoscope, Working Element
- EWQSaw, Surgical, Ent (Electric Or Pneumatic)
- FAMSigmoidoscope And Accessories, Flexible/Rigid
- FDISnare, Flexible
- EQHSource, Carrier, Fiberoptic Light
- EPYSpeculum, Ent
- EPPSplint, Nasal
- BSRStylet, Tracheal Tube
- ENZTelescope, Laryngeal-Bronchial
- FBQTrocar, Gastro-Urology
- BYYTube, Aspirating, Flexible, Connecting
- FCZTube, Smoke Removal, Endoscopic
- BTRTube, Tracheal (W/Wo Connector)
- BYXTubing, Pressure And Accessories
- EIAUnit, Operative Dental
- EZOUrethrotome
- DQIWithdrawal/Infusion Pump
- CAMYoke Assembly, Medical Gas
Recall records
Showing 25 of 90| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2794-2026 | Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1. | Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility. | Class II | Open, Classified | |
| Z-1064-2025 | KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6, 34cm, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1063-2025 | KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1062-2025 | KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1061-2025 | KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1060-2025 | KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1059-2025 | KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1058-2025 | KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6, 43cm, NON STERILE, RxONLY, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1057-2025 | KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1056-2025 | KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1055-2025 | KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1054-2025 | KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1053-2025 | KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1052-2025 | KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-1051-2025 | KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123 | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-0837-2025 | Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE | Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance. | Class II | Open, Classified | |
| Z-0363-2025 | Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC | Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S. | Class II | Open, Classified | |
| Z-0526-2025 | 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x 4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x 5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x 5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x | Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. | Class II | Open, Classified | |
| Z-3225-2024 | Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-3224-2024 | Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-3223-2024 | Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-3222-2024 | Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-3221-2024 | Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-3220-2024 | Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified | |
| Z-3219-2024 | Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain