GAE
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Snare, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2007: 2 · 2008: 20 · 2009: 6 · 2010: 10 · 2015: 10 · 2016: 9
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 |
|---|---|---|
| BIPOLAR SNARE (K950776) | Cook Urological, Inc. | 1995-04-18 |
| ACUFEX SUTURE RETRIEVER (K926036) | Acufex Microsurgical, Inc. | 1993-05-05 |
| ADVANCE SUTURE ABSORBABLE GUT SUTURE (K903174) | Advance Suture, Inc. | 1991-07-10 |
| ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE (K881224) | Acufex Microsurgical, Inc. | 1988-06-01 |
Track GAE automatically
Every clearance here is in the API, with alerts when new ones post.