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

Camera, Television, Endoscopic, Without Audio

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

FWF is the FDA product code for Camera, Television, Endoscopic, Without Audio, a class I device type, regulated under 21 CFR 878.4160. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FWF
Device name
Camera, Television, Endoscopic, 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
23
Ingested recalls
2

Clearances, product code FWF

By decision year
23 clearances under product code FWF with a decision year between 1984 and 2006, 1993 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FWF by decision year
YearClearances
19841
19862
19872
19881
19912
19921
19934
19943
19984
19992
20061

Applicants with the most clearances

Product code FWF
Applicants holding the most 510(k) clearances under product code FWF
ApplicantClearances
Angiolaz, Inc.3
A.Stein - Regulatory Affairs Consulting1
American Edwards Laboratories1
American Surgical Technologies Corp.1
Aspen Laboratories, Inc.1
Biometric Products, Inc.1
Concept, Inc.1
Envision Medical Corp.1
Frigitronics, Inc.1
FUJIFILM Healthcare Americas Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order