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

Applier, Staple, Surgical,

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

GEF is the FDA product code for Applier, Staple, Surgical,, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GEF
Device name
Applier, Staple, Surgical,
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
4
Ingested recalls
0

Clearances, product code GEF

By decision year
4 clearances under product code GEF with a decision year between 1983 and 1993, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GEF by decision year
YearClearances
19831
19851
19921
19931

Applicants with the most clearances

Product code GEF
Applicants holding the most 510(k) clearances under product code GEF
ApplicantClearances
3M Company1
American V. Mueller1
Microaire1
Richard-Allan Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order