Cleared Traditional

K231491 - TA? Stapler and Loading Unit with DST Series? Technology
(FDA 510(k) Clearance)

K231491 · Covidien · General & Plastic Surgery

Aug 2023

Decision

85d

Days

Class 2

Risk

K231491 is an FDA 510(k) clearance for the TA? Stapler and Loading Unit with DST Series? Technology. This device is classified as a Stapler, Surgical (Class II — Special Controls, product code GAG).

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on August 16, 2023, 85 days after receiving the submission on May 23, 2023.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4740. 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..

Submission Details

510(k) Number	K231491 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2023
Decision Date	August 16, 2023
Days to Decision	85 days
Submission Type	Traditional
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.