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

Spatula, Surgical, General & Plastic Surgery

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

GAF is the FDA product code for Spatula, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GAF
Device name
Spatula, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4800
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
5
Ingested recalls
1

Clearances, product code GAF

By decision year
5 clearances under product code GAF with a decision year between 1982 and 2003, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GAF by decision year
YearClearances
19821
19881
19891
19941
20031

Applicants with the most clearances

Product code GAF
Applicants holding the most 510(k) clearances under product code GAF
ApplicantClearances
Bio-Blitz, Inc.1
Kinetic Medical Products1
LeMaitre Vascular Inc.1
PMT Corp.1
Surgiquip, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 201 companies shown, in name order