Cleared Special

GIA Auto Suture Stapler with DST Series Technology

K221013 · Covidien · General & Plastic Surgery
May 2022
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K221013 is an FDA 510(k) clearance for the GIA Auto Suture Stapler with DST Series Technology, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on May 5, 2022, 30 days after receiving the submission on April 5, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K221013 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2022
Decision Date May 05, 2022
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GDW — Staple, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4750

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