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

Needle, Emergency Airway

21 CFR 868.5090 / Anesthesiology
FDA source (opens on fda.gov)

BWC is the FDA product code for Needle, Emergency Airway, a class II device type, regulated under 21 CFR 868.5090. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
BWC
Device name
Needle, Emergency Airway
Regulation
21 CFR 868.5090
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
14
Ingested recalls
2

Clearances, product code BWC

By decision year
14 clearances under product code BWC with a decision year between 1977 and 2020, 2001 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code BWC by decision year
YearClearances
19771
19791
19851
19951
19971
20012
20022
20051
20131
20161
20171
20201

Applicants with the most clearances

Product code BWC
Applicants holding the most 510(k) clearances under product code BWC
ApplicantClearances
Cook Inc.4
Cook Incorporated2
31st. Centruy Medical Corp.1
Ffrench Pocket Emergency Airway, Inc.1
Gilbert Surgical Instruments, Inc.1
Hyde, Vernon E., D.D.S.1
Intl. Medical Devices, Ltd.1
Abbott Medical1
Teleflex Medical1
VBM Medizintechnik GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order