DeviceClearance

Product code GAG— General Hospital

AEON Endoscopic Powered Stapler (3 models)

Classification name
Stapler, Surgical
Device class
Class 2
Regulation
21 CFR 878.4740
Advisory panel
General Hospital
Total cleared
43
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code GAG under 21 CFR 878.4740, via openFDA

Market context for product code GAG

FDA has cleared 43 devices under product code GAG between 1976 and 2026, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code GAG

Adverse events under product code GAG

product code GAG
Death
23
Injury
394
Malfunction
2,304
Other
6
Total
2,727

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code GAG

Data sourced from openFDA. This site is unofficial and independent of the FDA.