Karl Storz SE & Co. KG
TUTTLINGEN Baden-Wurttemberg, DE
KARL STORZ SE & CO. KG appears in FDA device records in TUTTLINGEN Baden-Wurttemberg, DE. FDA records list 26 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 26 510(k) clearances for Karl Storz SE & Co. KG between 2018 and 2026. The busiest year on record is 2025, with 7. The most recent is 2026, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 3 |
| 2023 | 4 |
| 2024 | 5 |
| 2025 | 7 |
| 2026 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261706 | Endomat Select (UP220) | HIG | Substantially Equivalent | |
| K252800 | KARL STORZ Endoscopic Accessories for Urology | OCZ | Substantially Equivalent | |
| K254228 | KARL STORZ Trocars with Valve Seals | GCJ | Substantially Equivalent | |
| K260003 | KARL STORZ Mediastinoscopes and Instruments | EWY | Substantially Equivalent | |
| K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | OWN | Substantially Equivalent | |
| K253972 | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | OWN | Substantially Equivalent | |
| K251731 | KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) | EOQ | Substantially Equivalent | |
| K250927 | KARL STORZ Cholangiography Set | GCJ | Substantially Equivalent | |
| K253411 | Miniature Telescope for Urology (27033AA) | FGB | Substantially Equivalent | |
| K250388 | ENDOFLATOR + | HIF | Substantially Equivalent | |
| K243653 | KARL STORZ HOPKINS Telescopes for Urology | FAJ | Substantially Equivalent | |
| K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | FGB | Substantially Equivalent | |
| K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) | FBO | Substantially Equivalent | |
| K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | FBO | Substantially Equivalent | |
| K241945 | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) | FGB | Substantially Equivalent | |
| K233372 | KARL STORZ Fiber Telescopes for Urology | FGB | Substantially Equivalent | |
| K232486 | KARL STORZ Monopolar Resectoscopes with HF Cable | FJL | Substantially Equivalent | |
| K232370 | Percutaneous Nephroscope System | FGA | Substantially Equivalent | |
| K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | OWN | Substantially Equivalent | |
| K232857 | KARL STORZ ICG Imaging System | OWN | Substantially Equivalent | |
| K232406 | KARL STORZ OR1™ SCB CONTROL (WU300) | ODA | Substantially Equivalent | |
| K230535 | KARL STORZ Urological Laser Accessories | GEX | Substantially Equivalent | |
| K201355 | Endomat Select, IBS Shaver Software, License | HIG | Substantially Equivalent | |
| K192090 | CMOS Video Rhino-Laryngoscope SSU | EOB | Substantially Equivalent | |
| K192523 | CMOS Video Esophagoscope SSU | EOX | Substantially Equivalent | |
| K180735 | Endomat Select | HIG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014342096 | 3014342096 | KARL STORZ SE & CO KG | Dr.-Karl-Storz-Str. 34, TUTTLINGEN Baden-Wurttemberg 78532 DE | 2026 | and 139 more, listed in full below |
| 3006546082 | 3006546082 | KARL STORZ SE & CO. KG | Elsa-Brandstrom-Weg 11-21, TUTTLINGEN Baden-Wurttemberg 78532 DE | 2026 | and 52 more, listed in full below |
| 3010707607 | 3010707607 | KARL STORZ SE & CO. KG | TAKE-OFF GEWERBEPARK 83, NEUHAUSEN OBECK Baden-Wurttemberg 78579 DE | 2026 | and 113 more, listed in full below |
| 9610617 | 3002808268 | KARL STORZ SE & CO. KG | Dr.-Karl-Storz-Str. 11, TUTTLINGEN Baden-Wurttemberg 78532 DE | 2026 | and 127 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- FDZAttachment, Eyepiece, For Insertion Of Prescription Lens
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)
- FAXBougie, Urological
- EOQBronchoscope (Flexible Or Rigid)
- FCYBulb, Inflation, For Endoscope
- EQJBur, Ear, Nose And Throat
- 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
- FFLDislodger, Stone, Basket, Ureteral, Metal
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- FASElectrode, Electrosurgical, Active, Urological
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- EOXEsophagoscope (Flexible Or Rigid)
- FFDEvacuator, Bladder, Manually Operated
- FCLForceps, Biopsy, Non-Electric
- FDSGastroscope And Accessories, Flexible/Rigid
- FFSImage, Illumination, Fiberoptic, For Endoscope
- DZNInstruments, Dental Hand
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- FGAKit, Nephroscope
- EQNLaryngoscope, Nasopharyngoscope
- CALLaryngoscope, Non-Rigid
- CCWLaryngoscope, Rigid
- EQLLaryngostroboscope
- FCWLight Source, Fiberoptic, Routine
- FCRLight Source, Photographic, Fiberoptic
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral
- FFKLithotriptor, Electro-Hydraulic
- FEOLithotriptor, Ultrasonic
- EWYMediastinoscope, Surgical
- EPTMicroscope, Surgical
- EOBNasopharyngoscope (Flexible Or Rigid)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- FECObturator, For Endoscope
- ERAOtoscope
- ETBProsthesis, Partial Ossicular Replacement
- FEQPump, Air, Non-Manual, For Endoscope
- BTAPump, Portable, Aspiration (Manual Or Powered)
- ETAReplacement, Ossicular Prosthesis, Total
- FDCResectoscope, Working Element
- FAMSigmoidoscope And Accessories, Flexible/Rigid
- FDISnare, Flexible
- EQHSource, Carrier, Fiberoptic Light
- EPYSpeculum, Ent
- ENZTelescope, Laryngeal-Bronchial
- FBQTrocar, Gastro-Urology
- FCZTube, Smoke Removal, Endoscopic
- BYXTubing, Pressure And Accessories
- EIAUnit, Operative Dental
- FGBUreteroscope And Accessories, Flexible/Rigid
- FGCUrethroscope
- EZOUrethrotome
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain