510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FWHClass I

Camera, Cine, Surgical, Without Audio

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

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

Classification record

Product code
FWH
Device name
Camera, Cine, 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
2
Ingested recalls
1

Clearances, product code FWH

By decision year
2 clearances under product code FWH with a decision year between 1982 and 1988, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FWH by decision year
YearClearances
19821
19881

Applicants with the most clearances

Product code FWH
Applicants holding the most 510(k) clearances under product code FWH
ApplicantClearances
Concept, Inc.1
Medical Dynamics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code