510(k) K153025 ยท FRG Wrap, Sterilization
Turbett Surgical Container
| Applicant | Turbett Surgical, LLC, Rochester NY, US |
| Decision | Substantially Equivalent, Jan 14, 2016 |
| Received | Oct 16, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2023 | Turbett Surgical, Inc. Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider Open, Classified |
FRG | None listed |
| Jan 30, 2023 | Turbett Surgical, Inc. Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider Open, Classified |
FRG | None listed |
| Aug 4, 2022 | Turbett Surgical, Inc. Turbett Surgical Container, TS1500 Terminated |
FRG | None listed |
| May 18, 2022 | TURBETT SURGICAL, LLC Turbett Surgical Container, TS1500 Open, Classified |
FRG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.