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

Stapler, Surgical

21 CFR 878.4740 / General Hospital
FDA source (opens on fda.gov)

GAG is the FDA product code for Stapler, Surgical, a class II device type, regulated under 21 CFR 878.4740. FDA's definition for this code reads: "A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses". As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
GAG
Device name
Stapler, Surgical
FDA definition
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
Regulation
21 CFR 878.4740
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
43
Ingested recalls
10

Clearances, product code GAG

By decision year
43 clearances under product code GAG with a decision year between 1976 and 2026, 1984 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GAG by decision year
YearClearances
19762
19773
19803
19811
19823
19832
19845
19853
19861
19881
19891
19933
19942
19961
19971
20221
20234
20243
20252
20261

Applicants with the most clearances

Product code GAG
Applicants holding the most 510(k) clearances under product code GAG
ApplicantClearances
Ethicon, Inc6
Medtronic, Inc.5
Ethicon Endo-Surgery Inc5
Davis & Geck, Inc.4
American V. Mueller3
Surgeons Choice, Inc.3
Edward Weck, Inc.2
Lexington Medical, Inc.2
United States Surgical, A Division of Tyco Healthc2
Covidien (Part of Medtronic)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 67 companies shown, in name order