510(k) K212656 · EOQ Bronchoscope (Flexible Or Rigid)
Flexible Intubation Video Endoscope Sterile (FIVE-S)
| Applicant | Karl Storz Endoscopy America, El Segundo CA, US |
| Decision | Substantially Equivalent, Dec 29, 2021 |
| Received | Aug 23, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212656
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2023 | Karl Storz Endoscopy Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only Open, Classified |
EOQ | None listed |
| Apr 1, 2022 | Karl Storz Endoscopy 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.