BYZ
9 FDA 510(k) clearances · Product code
57 daysmedian time to decision
102 days90th percentile
9clearances measured
FDA profile
- Official device name
- Trap, Sterile Specimen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 1997: 1 · 1999: 3 · 2001: 2
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 |
|---|---|---|
| ELECTROMEDICS TISSUE TRAP/ #TT280 (K925412) | Electromedics, Inc. | 1993-02-05 |
| MUCOUS SPECIMEN TRAP (K913643) | Medical Device Inspection Co., Inc. | 1991-10-10 |
| TISSUE/POLYP TRAP SYSTEM (K902883) | Triton Technology, Inc. | 1990-09-12 |
| BUSH NECK W/PLUG (K841409) | Warne Surgical Products, Ltd. | 1984-04-18 |
| ONE-WAY AIR VALVE (K840253) | Delta Medical Industries | 1984-04-05 |
| SPECIMEN TRAP (K834467) | Microvasive | 1984-02-17 |
| CRITICAL MEASUREMENT UNIT (K822556) | Bemis Health Care | 1982-10-18 |
| SPECIMEN ADAPTOR (K822557) | Bemis Health Care | 1982-10-18 |
| ASPRI-LUKE (K791847) | Medical Marketing Group | 1979-10-02 |
Track BYZ automatically
Every clearance here is in the API, with alerts when new ones post.