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

Light, Surgical, Endoscopic

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

FSW is the FDA product code for Light, Surgical, Endoscopic, a class II device type, regulated under 21 CFR 878.4580. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FSW
Device name
Light, Surgical, Endoscopic
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
8
Ingested recalls
0

Clearances, product code FSW

By decision year
8 clearances under product code FSW with a decision year between 1987 and 2002, 2002 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FSW by decision year
YearClearances
19871
19891
19911
19921
19931
19941
20022

Applicants with the most clearances

Product code FSW
Applicants holding the most 510(k) clearances under product code FSW
ApplicantClearances
Aculux1
Cuda Products Co.1
Genzyme Biosurgery1
Leisegang Medical, Inc.1
M.P. Video, Inc.1
Medical Dynamics, Inc.1
Medical Illumination, Inc.1
MEDLINE INDUSTRIES, LP - Northfield1

Companies listing this code with FDA

Companies whose registered establishments list this code