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
FSSClass II

Light, Surgical, Floor Standing

21 CFR 878.4580 / General, Plastic Surgery
FDA source (opens on fda.gov)

FSS is the FDA product code for Light, Surgical, Floor Standing, a class II device type, regulated under 21 CFR 878.4580. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FSS
Device name
Light, Surgical, Floor Standing
Regulation
21 CFR 878.4580
Device class
Class II
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
0

Clearances, product code FSS

By decision year
20 clearances under product code FSS with a decision year between 1986 and 2009, 1989 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FSS by decision year
YearClearances
19861
19883
19894
19911
19931
19962
19971
19984
19991
20011
20091

Applicants with the most clearances

Product code FSS
Applicants holding the most 510(k) clearances under product code FSS
ApplicantClearances
Cuda Products Co.3
Kinetic Biomedical Services, Inc.2
Adel Medical, Ltd.1
Aesculap Inc1
American Sterilizer Co.1
Angiolaz, Inc.1
Astralite Corp.1
Commercial Products & Engineering Co.1
F.W. Lang Co.1
Ferguson Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 36 companies shown, in name order