510(k) K971832 ยท HOZ Sponge, Ophthalmic
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
| Applicant | M-Pact Worldwide Management Corp., Eudora KS, US |
| Decision | Substantially Equivalent, Jul 31, 1997 |
| Received | May 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971832
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2025 | Carwild Corporation Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site.
Model Number: Q604206 Open, Classified |
HOZ | None listed |
| Jan 2, 2025 | Carwild Corporation Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During
Ophthalmic Surgical Procedures For Fluid Management
Model Number: Q604237 Open, Classified |
HOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.