BWB
6 FDA 510(k) clearances · Product code
55 daysmedian time to decision
57 days90th percentile
6clearances measured
FDA profile
- Official device name
- Forceps, Tube Introduction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5780
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 2010: 4
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 |
|---|---|---|
| TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS (K884584) | Eastmed Enterprises, Inc. | 1988-11-14 |
| ROVENSTEIN FORCEPS (K880318) | Eastmed Enterprises, Inc. | 1988-03-21 |
| MAGILL FORCEPS (K880319) | Eastmed Enterprises, Inc. | 1988-03-21 |
| CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV (K840313) | Imm Enterprises , Ltd. | 1984-02-04 |
| OP-CON SURGICAL INSTRUMENT #9 (K834169) | Imm Enterprises , Ltd. | 1984-01-17 |
| INTRODUCER FOR ENDOTRACHEAL TUBE (K820451) | Imed Corp. | 1982-03-26 |
Track BWB automatically
Every clearance here is in the API, with alerts when new ones post.