510(k) K201945 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
KARL STORZ UDEL Sterilization Trays
| Applicant | Karl Storz Endoscopy America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Feb 25, 2021 |
| Received | Jul 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201945
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2021 | Karl Storz Endoscopy Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description:
39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA HEADS);
39301AS/RIGID TELESCOPE TRAY (STERRAD, 2 RIGID SCOPES 4MM X Open, Classified |
KCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.