510(k) K802458 ยท HFB Forceps, Biopsy, Gynecological
KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611
| Applicant | J. Sklar Mfg. Co., Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 12, 1981 |
| Received | Oct 8, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802458
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113;
2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A;
3) E Open, Classified |
HCY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.