510(k) K801273 ยท KOA Surgical Instruments, G-U, Manual (And Accessories)
MAGILL CATHETER INTRO. FORCEPS
| Applicant | J. Sklar Mfg. Co., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 28, 1980 |
| Received | May 29, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K801273
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286;
2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290;
3) ECONO STERIL Open, Classified |
GEN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.