Cleared Traditional

Vas-Q-Clip

K151943 · Nanova Biomaterials, Inc. · General & Plastic Surgery
Mar 2016
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K151943 is an FDA 510(k) clearance for the Vas-Q-Clip, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Nanova Biomaterials, Inc. (Columbia, US). The FDA issued a Cleared decision on March 25, 2016, 255 days after receiving the submission on July 14, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K151943 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2015
Decision Date March 25, 2016
Days to Decision 255 days
Submission Type Traditional
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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