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FDA PRODUCT CODE · CLASS II

GAG — Stapler, Surgical

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4740
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K253527Covidien, LLC · 510k2026-07-01
K251482Lexington Medical, Inc. · 510k2025-07-11
K243596Intuitive Surgical, Inc. · 510k2025-03-10
K240881Covidien (Part of Medtronic) · 510k2024-11-01

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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