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

Needle, Suturing, Disposable

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

GAB is the FDA product code for Needle, Suturing, Disposable, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
GAB
Device name
Needle, Suturing, Disposable
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
8
Ingested recalls
7

Clearances, product code GAB

By decision year
8 clearances under product code GAB with a decision year between 1980 and 2001, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GAB by decision year
YearClearances
19801
19811
19831
19861
19891
19931
19981
20011

Applicants with the most clearances

Product code GAB
Applicants holding the most 510(k) clearances under product code GAB
ApplicantClearances
Anchor Products Co.1
Applied Medical Technologies1
TORNIER Inc.1
Devon Industries, Inc.1
Humana USA, Inc.1
Scanlan Intl., Inc.1
Sharpoint, Inc.1
Synergistic Medical Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 110 companies shown, in name order