KGY
6 FDA 510(k) clearances · Product code
108 daysmedian time to decision
183 days90th percentile
6clearances measured
FDA profile
- Official device name
- Bag, Intestine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4100
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2020: 14 · 2021: 14 · 2022: 20 · 2023: 17 · 2024: 18 · 2026: 16
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 |
|---|---|---|
| GOODMAN BANDAGE (K933085) | Megadyne Medical Products, Inc. | 1993-12-23 |
| TROCAR CATHETER (K913678) | Medovations, Inc. | 1991-12-16 |
| SURGICAL TISSUE POUCH (K910914) | Cook Urological, Inc. | 1991-03-28 |
| ISOLATION BAG 3M (K832318) | 3M Company | 1983-10-31 |
| BAND-AID BRAND TRICOT MESH BANDAGES (K801823) | Johnson & Johnson Professionals, Inc. | 1980-08-20 |
| BAND-AID BRAND FLEXIBLE FABRIC BANDAGE (K801824) | Johnson & Johnson Professionals, Inc. | 1980-08-20 |
Track KGY automatically
Every clearance here is in the API, with alerts when new ones post.