510(k) K003214 ยท ETB Prosthesis, Partial Ossicular Replacement
SMITH & NEPHEW PISTONS
| Applicant | Gyrus Ent LLC, Bartlett TN, US |
| Decision | Substantially Equivalent, Oct 31, 2000 |
| Received | Oct 13, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003214
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2020 | Olympus Corporation of the Americas Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement
Catalog Number: 70142168 Terminated |
ETB | None listed |
| Jul 14, 2020 | Olympus Corporation of the Americas Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement
Catalog Number: 70143662 Terminated |
ETB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.