Cleared Traditional

PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES

K051301 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery
Aug 2005
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K051301 is an FDA 510(k) clearance for the PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, 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 August 30, 2005, 103 days after receiving the submission on May 19, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K051301 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2005
Decision Date August 30, 2005
Days to Decision 103 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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