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510(k) K232126

EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil by Covidien — Product Code GAG

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 16, 2023
Date Received: July 17, 2023
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Stapler, Surgical
Device Class: Class II
Regulation Number: 878.4740
Review Panel: SU
Submission Type

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.

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Other clearances for product code GAG

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K243596 — da Vinci SP SureForm 45 Staplers and Reloads (SP1098) (March 10, 2025)
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K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (July 3, 2024)
K234039 — AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (May 7, 2024)
K231934 — GIA Stapler with Tri-Staple Technology (October 27, 2023)
K231491 — TA Stapler and Loading Unit with DST Series Technology (August 16, 2023)
K221629 — Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) (February 22, 2023)
K213633 — ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (April 8, 2022)
K970079 — PROXIMATE DISPOSABLE SKIN STAPLER (March 11, 1997)