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

Adaptor, Catheter

21 CFR 878.4200 / General, Plastic Surgery
FDA source (opens on fda.gov)

GCE is the FDA product code for Adaptor, Catheter, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
GCE
Device name
Adaptor, Catheter
Regulation
21 CFR 878.4200
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 GCE

By decision year
4 clearances under product code GCE with a decision year between 1980 and 1990, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code GCE by decision year
YearClearances
19801
19861
19902

Applicants with the most clearances

Product code GCE
Applicants holding the most 510(k) clearances under product code GCE
ApplicantClearances
Jeff Klein Surgical, Inc.2
Mediflex Intl.1
Quinton, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order