510(k) K203198 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
KARL STORZ Metal Sterilization Trays
| Applicant | Karl Storz Endoscopy America, Inc., El Segundo CA, US |
| Decision | Substantially Equivalent, Jul 6, 2021 |
| Received | Oct 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203198
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2023 | Karl Storz Endoscopy Metal Tray, 178 x 135 x 37 mm, REF: 11580A;
Metal Tray, 275 x 178 x 35 mm, REF: 11580B;
Metal Tray, 373 x 178 x 35 mm, REF: 11580C;
Metal Tray, 275 x 175 x 37 mm, REF: 11580D;
Wire Tray f. Cleaning, 2 Open, Classified |
KCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.