GAF
5 FDA 510(k) clearances · Product code
23 daysmedian time to decision
90 days90th percentile
5clearances measured
FDA profile
- Official device name
- Spatula, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER (K023688) | LeMaitre Vascular, Inc. | 2003-01-30 | + Add |
| SNAP RECIPROCATING SAW (K935357) | Surgiquip, Inc. | 1994-01-28 | + Add |
| ABDOMINAL SPATULA (K890374) | Kinetic Medical Products | 1989-02-03 | + Add |
| PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE (K882793) | Pmt Corp. | 1988-07-18 | + Add |
| CEMENT-PICK (K822108) | Bio-Blitz, Inc. | 1982-08-11 | + Add |
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Every clearance here is in the API, with alerts when new ones post.