510(k) K932166 ยท ETD Tube, Tympanostomy
SILICONE TYMPANOSTOMY TUBES
| Applicant | Smith & Nephew Richards, Inc., Bartlett TN, US |
| Decision | Substantially Equivalent, Jul 26, 1993 |
| Received | May 4, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2024 | Olympus Corporation of the Americas Duravent Silicone Ventilation Tube. Model Number: 240075. Open, Classified |
ETD | None listed |
| Feb 7, 2024 | Olympus Corporation of the Americas Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media
Model: 240044 Open, Classified |
ETD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.