GDH
6 FDA 510(k) clearances · Product code
19 daysmedian time to decision
38 days90th percentile
6clearances measured
FDA profile
- Official device name
- Gouge, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2005: 2 · 2006: 5 · 2007: 5 · 2014: 7 · 2015: 12 · 2017: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE (K903419) | United States Surgical, A Division of Tyco Healthc | 1990-08-09 | + Add |
| MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE (K900487) | United States Surgical, A Division of Tyco Healthc | 1990-02-09 | + Add |
| GOUGES, ALEXANDER, BISHOP, LUCAS (K891901) | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | + Add |
| AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE (K874879) | United States Surgical, A Division of Tyco Healthc | 1987-12-17 | + Add |
| CHERMEL BONE GOUGES (K842822) | Cher Mel Corp. | 1984-08-02 | + Add |
| PARKES HUMP GAUGE STRAIGHT 7 (18 CM) (K760850) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-03 | + Add |
Track GDH automatically
Every clearance here is in the API, with alerts when new ones post.