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

Carrier, Ligature

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

GEJ is the FDA product code for Carrier, Ligature, 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 4 recalls.

Classification record

Product code
GEJ
Device name
Carrier, Ligature
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
4

Clearances, product code GEJ

By decision year
5 clearances under product code GEJ with a decision year between 1987 and 2024, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GEJ by decision year
YearClearances
19871
19881
19902
20241

Applicants with the most clearances

Product code GEJ
Applicants holding the most 510(k) clearances under product code GEJ
ApplicantClearances
Solos Endoscopy, Inc.2
Cook Ob/Gyn1
Cox-Uphuff Intl.1
Cypris Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 69 companies shown, in name order