FSH
8 FDA 510(k) clearances · Product code
31 daysmedian time to decision
65 days90th percentile
8clearances measured
FDA profile
- Official device name
- Tray, Surgical, Needle
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2012: 5 · 2017: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| S 4 INSTRUMENT STAND (K884876) | Carl Zeiss, Inc. | 1988-12-15 |
| S 21 INSTRUMENT STAND (K883578) | Carl Zeiss, Inc. | 1988-09-13 |
| STAND, SURG. INSTRUMENT & DRESSING (K821921) | Emerson-Sack-Warner Corp. | 1982-07-30 |
| SKINNY CHIBA NEEDLE & TRAY (K813337) | American Pharmaseal Div. Ahsc | 1982-01-28 |
| BIOPSY NEEDLES & TRAYS (K813338) | American Pharmaseal Div. Ahsc | 1982-01-28 |
| PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY (K813335) | American Pharmaseal Div. Ahsc | 1982-01-08 |
| MODEL 902 STAND (K780759) | Applied Medical Research | 1978-05-19 |
| FSH RIA KIT (125I) (K772188) | Diagnostic Products Corp. | 1977-12-22 |
Track FSH automatically
Every clearance here is in the API, with alerts when new ones post.