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

Table And Attachments, Operating-Room

21 CFR 878.4950 / General, Plastic Surgery
FDA source (opens on fda.gov)

BWN is the FDA product code for Table And Attachments, Operating-Room, a class I device type, regulated under 21 CFR 878.4950. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 74 recalls.

Classification record

Product code
BWN
Device name
Table And Attachments, Operating-Room
Regulation
21 CFR 878.4950
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
20
Ingested recalls
74

Clearances, product code BWN

By decision year
20 clearances under product code BWN with a decision year between 1979 and 1994, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code BWN by decision year
YearClearances
19791
19802
19812
19821
19832
19841
19851
19861
19871
19882
19901
19911
19932
19942

Applicants with the most clearances

Product code BWN
Applicants holding the most 510(k) clearances under product code BWN
ApplicantClearances
Northwest Surgical Concepts, Inc.2
Alpha Surgical, Inc.1
American Sterilizer Co.1
David Simmonds Co., Inc.1
Dyonics, Inc.1
Edgewater Medical Equipment Systems1
Ets Rene Marzet1
Infinitech, Inc.1
Instrumentation Specialties, Inc.1
Kamiya Tsusan Kaisha, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 146 companies shown, in name order