Cleared Special

FasTouch Fixation System (K162252) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K162252 · Via Surgical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
96d
Days
Class 2
Risk

K162252 is an FDA 510(k) clearance for the FasTouch Fixation System. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Via Surgical , Ltd. (Moshav Amirim, IL). The FDA issued a Cleared decision on November 14, 2016 after a review of 96 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Via Surgical , Ltd. devices

Submission Details

510(k) Number K162252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2016
Decision Date November 14, 2016
Days to Decision 96 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 129
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K162252.
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CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners
K160900 · C.R. Bard, Inc. · May 2016
Signia Stapler
K160176 · Covidien · Apr 2016
OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners
K142873 · C.R. Bard, Inc. · Mar 2015