510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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BWBClass I

Forceps, Tube Introduction

21 CFR 868.5780 / Anesthesiology
FDA source (opens on fda.gov)

BWB is the FDA product code for Forceps, Tube Introduction, a class I device type, regulated under 21 CFR 868.5780. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
BWB
Device name
Forceps, Tube Introduction
Regulation
21 CFR 868.5780
Device class
Class I
Review panel
Anesthesiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
1

Clearances, product code BWB

By decision year
6 clearances under product code BWB with a decision year between 1982 and 1988, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code BWB by decision year
YearClearances
19821
19842
19883

Applicants with the most clearances

Product code BWB
Applicants holding the most 510(k) clearances under product code BWB
ApplicantClearances
Eastmed Enterprises, Inc.3
Imm Enterprises, Ltd.2
Imed Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 64 companies shown, in name order