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

Light, Surgical, Fiberoptic

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

FST is the FDA product code for Light, Surgical, Fiberoptic, a class II device type, regulated under 21 CFR 878.4580. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
FST
Device name
Light, Surgical, Fiberoptic
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
45
Ingested recalls
12

Clearances, product code FST

By decision year
45 clearances under product code FST with a decision year between 1977 and 2020, 1988 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FST by decision year
YearClearances
19771
19861
19871
19885
19892
19903
19911
19924
19942
19961
19981
19991
20001
20011
20041
20051
20062
20071
20082
20093
20105
20123
20141
20201

Applicants with the most clearances

Product code FST
Applicants holding the most 510(k) clearances under product code FST
ApplicantClearances
Advanced Surgical Products, Inc.5
Cuda Products Co.3
Invuity, Inc.2
Medical Illumination International, Inc2
STERIS Corporation2
Sensormed2
Bfw, Inc.1
Cogent Light Technologies, Inc.1
Designs for Vision, Inc.1
Enroxtech, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 66 companies shown, in name order