GDI
7 FDA 510(k) clearances · Product code
43 daysmedian time to decision
139 days90th percentile
7clearances measured
FDA profile
- Official device name
- Dissector, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2007: 55 · 2008: 45 · 2009: 21 · 2010: 8 · 2012: 7 · 2024: 20
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 |
|---|---|---|
| DISPOSABLE EXTERNAL CLAMPS (K896383) | Galenica Enterprises, Inc. | 1989-12-06 |
| HEPATIC PARENCHYMAL SUCTION DISSECTOR (K850288) | Beecher Medical Diagnostic Instrumentation | 1985-03-18 |
| ROUND-BEEHIVE- DISSECTORS 3/8 (K831912) | Ormed Mfg., Inc. | 1983-10-31 |
| TYMPANOPLASTY & SKIN DISSECTORS (K822569) | Kelleher Corp. | 1982-10-06 |
| FIELD SUCTION DISSECTOR (K803292) | V. Mueller O.V. Baxter Healthcare Corp. | 1981-01-29 |
| DISPOSABLE SPECIALITY SPONGES (K791870) | Carwild Corp. | 1979-11-05 |
| TEW BYPASS INSTRUMENTS & DISSECTING KIT (K791703) | Edward Weck, Inc. | 1979-10-04 |
Track GDI automatically
Every clearance here is in the API, with alerts when new ones post.