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

Applier, Surgical, Clip

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

GDO is the FDA product code for Applier, Surgical, Clip, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
GDO
Device name
Applier, Surgical, Clip
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
14
Ingested recalls
8

Clearances, product code GDO

By decision year
14 clearances under product code GDO with a decision year between 1977 and 1993, 1979 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GDO by decision year
YearClearances
19773
19795
19811
19821
19893
19931

Applicants with the most clearances

Product code GDO
Applicants holding the most 510(k) clearances under product code GDO
ApplicantClearances
Edward Weck, Inc.4
Ethicon, Inc3
United States Surgical, A Division of Tyco Healthc2
C. Intl.1
Dhason Brothers, Inc.1
Hartmann Group, Inc.1
Kinetic Medical Products1
Unisurge, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 143 companies shown, in name order