Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K213633Substantially Equivalent

ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler

Ethicon Endo-Surgery Inc, Guaynabo PR / Traditional, Substantially Equivalent

K213633 is the FDA 510(k) clearance record for ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler, a class II device, cleared for Ethicon Endo-Surgery, LLC on under FDA product code GAG (Stapler, Surgical). FDA's definition for product code GAG 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". FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, LLC, from to . As of , FDA records show no recalls naming K213633.

Clearance record

Decision date
Received
(142 days to decision)
Product code
GAG Stapler, Surgical
Regulation
21 CFR 878.4740
Device class
Class II
Review panel
General Hospital
Applicant
Ethicon Endo-Surgery, LLC 475 Calle C, Guaynabo PR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAG

Trailing 12 months
1 clearance under product code GAG in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260