KARL STORZ Endovision, Inc.
Charlton, MA, US
KARL STORZ ENDOVISION, INC. appears in FDA device records in Charlton, MA. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for KARL STORZ Endovision, Inc. in 2024.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232911 | KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) | FGB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1221826 | 1221826 | KARL STORZ ENDOVISION, INC. | 91 Carpenter Hill Rd, CHARLTON, MA 01507 US | 2026 | and 21 more, listed in full below |
| 3032429484 | 3032429484 | KARL STORZ Endovision, Inc. | 1376 W Central St Ste 50, Franklin, MA 02038 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYKAngioscope
- HRXArthroscope
- EOQBronchoscope (Flexible Or Rigid)
- FWFCamera, Television, Endoscopic, Without Audio
- FBNCholedochoscope And Accessories, Flexible/Rigid
- FDFColonoscope And Accessories, Flexible/Rigid
- FAJCystoscope And Accessories, Flexible/Rigid
- FBOCystourethroscope
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GWGEndoscope, Neurological
- OCXEndoscopic Irrigation/Suction System
- EOXEsophagoscope (Flexible Or Rigid)
- FDSGastroscope And Accessories, Flexible/Rigid
- HIHHysteroscope (And Accessories)
- FFSImage, Illumination, Fiberoptic, For Endoscope
- HIGInsufflator, Hysteroscopic
- HIFInsufflator, Laparoscopic
- FGAKit, Nephroscope
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- CALLaryngoscope, Non-Rigid
- CCWLaryngoscope, Rigid
- OAYLight Source System, Diagnostic Endoscopic
- GCTLight Source, Endoscope, Xenon Arc
- FCWLight Source, Fiberoptic, Routine
- FCRLight Source, Photographic, Fiberoptic
- EOBNasopharyngoscope (Flexible Or Rigid)
- ERAOtoscope
- FAMSigmoidoscope And Accessories, Flexible/Rigid
- MQWTransilluminator, Fiber Optic
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1333-2016 | ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL | Endoscope cleaning brush 11276CL may not fit resulting in an inability to insert the brush in to the channel of the intended endoscope or to completely pass it through such channel. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain