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

Camera, Television, Surgical, Without Audio

21 CFR 878.4160 / General, Plastic Surgery
FDA source (opens on fda.gov)

FWB is the FDA product code for Camera, Television, Surgical, Without Audio, a class I device type, regulated under 21 CFR 878.4160. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FWB
Device name
Camera, Television, Surgical, Without Audio
Regulation
21 CFR 878.4160
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
6
Ingested recalls
2

Clearances, product code FWB

By decision year
6 clearances under product code FWB with a decision year between 1982 and 1994, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FWB by decision year
YearClearances
19821
19861
19871
19881
19901
19941

Applicants with the most clearances

Product code FWB
Applicants holding the most 510(k) clearances under product code FWB
ApplicantClearances
M.P. Video, Inc.2
Envision Medical Corp.1
MEDLINE INDUSTRIES, LP - Northfield1
Seitz Technical Products, Inc.1
Sony Corp. of America1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order