Cleared Traditional

K151943 - Vas-Q-Clip

K151943 is an FDA 510(k) clearance for Vas-Q-Clip, manufactured by Nanova Biomaterials, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K151943 · Nanova Biomaterials, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
255d
Days
Class 2
Risk

K151943 is an FDA 510(k) clearance for the Vas-Q-Clip. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Nanova Biomaterials, Inc. (Columbia, US). The FDA issued a Cleared decision on March 25, 2016 after a review of 255 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Nanova Biomaterials, Inc. devices

FDA 510(k) Submission Details - K151943

510(k) Number K151943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 115d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZP Clip, Implantable

All 105
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K151943.
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
K172742 · AtriCure, Inc. · Oct 2017
AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
K163261 · AtriCure, Inc. · May 2017
Weck Auto Endo10 Automatic Endoscopic Clip Applier
K161758 · Teleflex Medical · Sep 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
K160454 · AtriCure, Inc. · Mar 2016
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
K153500 · AtriCure, Inc. · Jan 2016
SureClip
K150936 · Conmed Corporation · Oct 2015