510(k) K233372 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
KARL STORZ Fiber Telescopes for Urology
| Applicant | Karl Storz SE & CO. KG, Tuttlingen, DE |
| Decision | Substantially Equivalent, Jul 25, 2024 |
| Received | Oct 2, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233372
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6, 43cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6, 43 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6, 34 cm, NON STERILE, RxONLY, CE 0123 Open, Classified |
FGB | None listed |
| Jan 30, 2025 | Karl Storz Endoscopy KARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6, 34cm, CE 0123 Open, Classified |
FGB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.