GEE
7 FDA 510(k) clearances · Product code
32 daysmedian time to decision
91 days90th percentile
7clearances measured
FDA profile
- Official device name
- Brush, Biopsy, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1994: 2 · 1995: 1 · 2001: 1
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 |
|---|---|---|
| STERILE SOFT TISSUE BIOPSY NEEDLE (K854003) | Co-Medical, Inc. | 1985-10-18 |
| BIOPSY PUNCH, VARIOUS (K841008) | Premier Dental Products Co. | 1984-06-08 |
| DEFLECTING CYTOLOGY BRUSH (K822490) | Van-Tec, Inc. | 1982-09-14 |
| STERILE CYTOLOGY BRUSHES (K820259) | American Endoscopy, Inc. | 1982-03-05 |
| WHISK-R (K812694) | Medi-Spec | 1981-10-26 |
| CAMLOC SYRINGE BIOPSY KIT (K801304) | Johannah Medical Services, Inc. | 1980-06-17 |
| TROTEX II SCREW NEEDLE BIOPSY INSTR. SET (K792316) | Ursus Konsult AB | 1979-12-18 |
Track GEE automatically
Every clearance here is in the API, with alerts when new ones post.