Panels › Obstetrics/Gynecology › Product code HFB · Class 1
Forceps, Biopsy, Gynecological
Regulation 884.4530
0510(k)s in 12 months (22 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in HFB
| Company | 510(k)s | Recalls |
|---|---|---|
| J. Sklar Mfg. Co., Inc. | 3 | 0 |
| Thomasville Medical Assoc. | 3 | 0 |
| Zinnanti Surgical Instruments, Inc. | 3 | 0 |
| Advanced Biomedical Instruments | 1 | 0 |
| Chirurgische Instrumente | 1 | 0 |
| Gyneco, Inc. | 1 | 0 |
| Gynescope Corp. | 1 | 0 |
| The Huxley Instrument Corp. | 1 | 0 |
| Kinetic Medical Products | 1 | 0 |
| Mahe-Medizintechnik | 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 MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M;
2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynec Open, Classified |
HFB | K772229 |
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