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

Light, Surgical, Accessories

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

FTA is the FDA product code for Light, Surgical, Accessories, a class II device type, regulated under 21 CFR 878.4580. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
FTA
Device name
Light, Surgical, Accessories
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
26
Ingested recalls
5

Clearances, product code FTA

By decision year
26 clearances under product code FTA with a decision year between 1978 and 2015, 1989 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FTA by decision year
YearClearances
19781
19811
19861
19871
19881
19894
19901
19921
19941
19961
19991
20022
20031
20051
20061
20081
20101
20121
20143
20151

Applicants with the most clearances

Product code FTA
Applicants holding the most 510(k) clearances under product code FTA
ApplicantClearances
Karl Storz Endoscopy-America, Inc.3
Image Stream Medical, Inc.2
Transmedical Corp.2
American Medical Mfg., Inc.1
Aspen Surgical Products, Inc.1
Black Diamond Video, Inc.1
Burton Medical Products Corp.1
Cavitron Corp.1
Charles Polo & Co., Inc.1
Deroyal Cardiovascular, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 75 companies shown, in name order