Atlas FDA

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.
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RecordFirmDate
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

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Every clearance here is in the API, with alerts when new ones post.