Panels › Gastroenterology, Urology › Product code FBX · Class 1
Sound, Urethral, Metal Or Plastic
Regulation 876.5520
0510(k)s in 12 months (1 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in FBX
| Company | 510(k)s | Recalls |
|---|---|---|
| Candela Laser Corp. | 1 | 0 |
| Sklar Instruments | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use) Open, Classified |
FBX | None listed |
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