510(k) K232370 ยท FGA Kit, Nephroscope
Percutaneous Nephroscope System
| Applicant | Karl Storz SE & CO. KG, Tuttlingen, DE |
| Decision | Substantially Equivalent, May 1, 2024 |
| Received | Aug 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 Open, Classified |
FGA | None listed |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 Open, Classified |
FGA | None listed |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 Open, Classified |
FGA | None listed |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 Open, Classified |
FGA | None listed |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 Open, Classified |
FGA | None listed |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123 Open, Classified |
FGA | None listed |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 Open, Classified |
FGA | None listed |
| Sep 24, 2024 | Karl Storz Endoscopy Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123 Open, Classified |
FGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.