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

Snare, Surgical

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

GAE is the FDA product code for Snare, 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 3 recalls.

Classification record

Product code
GAE
Device name
Snare, 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
3

Clearances, product code GAE

By decision year
4 clearances under product code GAE with a decision year between 1988 and 1995, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GAE by decision year
YearClearances
19881
19911
19931
19951

Applicants with the most clearances

Product code GAE
Applicants holding the most 510(k) clearances under product code GAE
ApplicantClearances
Acufex Microsurgical, Inc.2
Advance Suture, Inc.1
Cook Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 59 companies shown, in name order