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

Cannula, Surgical, General & Plastic Surgery

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

GEA is the FDA product code for Cannula, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 24 recalls.

Classification record

Product code
GEA
Device name
Cannula, 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
36
Ingested recalls
24

Clearances, product code GEA

By decision year
36 clearances under product code GEA with a decision year between 1981 and 2001, 1990 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GEA by decision year
YearClearances
19811
19834
19844
19852
19864
19874
19881
19894
19905
19912
19922
19951
19991
20011

Applicants with the most clearances

Product code GEA
Applicants holding the most 510(k) clearances under product code GEA
ApplicantClearances
Ethicon, Inc3
Jeff Klein Surgical, Inc.3
Axiom Medical, Inc.2
Wells Johnson Co.2
Advanced Biosearch Assn.1
Advantage Diagnostics Corp.1
Aesculap Inc1
American Instrument Manufacturer'S, Inc.1
American Silk Sutures, Inc.1
Apex Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 340 companies shown, in name order