510(k) K221591 ยท GCJ Laparoscope, General & Plastic Surgery
Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
| Applicant | Schoelly Fiberoptic GmbH, Denzlingen, DE |
| Decision | Substantially Equivalent, Feb 23, 2023 |
| Received | Jun 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221591
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.