Panels › Obstetrics/Gynecology › Product code HCY · Class 1
Curette, Uterine
Regulation 884.4530
0510(k)s in 12 months (11 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in HCY
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corp | 1 | 0 |
| British Marketing Ent., Ltd. | 1 | 0 |
| D.L. Nelson and Assoc., Inc. | 1 | 0 |
| Gynemetrics, Inc. | 1 | 0 |
| Imagyn Medical Technologies, Inc. | 1 | 0 |
| Ivory Instruments Co. | 1 | 0 |
| Kinetic Medical Products | 1 | 0 |
| Luneau Laboratories | 1 | 0 |
| Nu-Gyn-Tek, Inc. | 1 | 0 |
| Phase I Corp. | 1 | 0 |
| 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 | K772229 K802458 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.