Cleared Special

GIA Stapler with Tri-Staple Technology

K221006 · Covidien · General & Plastic Surgery
Apr 2022
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K221006 is an FDA 510(k) clearance for the GIA Stapler with Tri-Staple Technology, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Covidien (Min Hang District, Shanghai, CN). The FDA issued a Cleared decision on April 29, 2022, 24 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 K221006 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2022
Decision Date April 29, 2022
Days to Decision 24 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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