Cleared Special

Signia Stapler (with new software)

K201672 · Covidien · General & Plastic Surgery
Jul 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K201672 is an FDA 510(k) clearance for the Signia Stapler (with new software), a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on July 17, 2020, 28 days after receiving the submission on June 19, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K201672 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2020
Decision Date July 17, 2020
Days to Decision 28 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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