Cleared Special

EEA?Circular Stapler with Tri-Staple? Technology and OrVil? Transoral Circular Stapler Anvil

K232126 · Covidien · General & Plastic Surgery

Aug 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K232126 is an FDA 510(k) clearance for the EEA?Circular Stapler with Tri-Staple? Technology and OrVil? Transoral Circular Stapler Anvil, a Stapler, Surgical (Class II — Special Controls, product code GAG), submitted by Covidien (Min Hang District, Shanghai, CN). The FDA issued a Cleared decision on August 16, 2023, 30 days after receiving the submission on July 17, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4740.

Submission Details

510(k) Number	K232126 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 2023
Decision Date	August 16, 2023
Days to Decision	30 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GAG — Stapler, Surgical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4740
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.