Cleared Traditional

CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G

K091322 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery
Jun 2009
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K091322 is an FDA 510(k) clearance for the CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 1, 2009, 27 days after receiving the submission on May 5, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K091322 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2009
Decision Date June 01, 2009
Days to Decision 27 days
Submission Type Traditional
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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