Cleared Special

Weck Auto Endo5 Hem-o-lok Ligating Clip Applier

K152081 · Teleflexmedical, Inc. · General & Plastic Surgery
Aug 2015
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K152081 is an FDA 510(k) clearance for the Weck Auto Endo5 Hem-o-lok Ligating Clip Applier, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on August 26, 2015, 30 days after receiving the submission on July 27, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K152081 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2015
Decision Date August 26, 2015
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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