Cleared Traditional

K132698 - FASTOUCH FIXATION SYSTEM

K132698 is an FDA 510(k) clearance for FASTOUCH FIXATION SYSTEM, manufactured by Via Surgical , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K132698 · Via Surgical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
197d
Days
Class 2
Risk

K132698 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. (Providence, US). The FDA issued a Cleared decision on March 14, 2014 after a review of 197 days - an extended review cycle.

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. 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 Via Surgical , Ltd. devices

FDA 510(k) Submission Details - K132698

510(k) Number K132698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2013
Decision Date March 14, 2014
Days to Decision 197 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
82d slower than avg
Panel avg: 115d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

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 184
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K132698.
ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
K141952 · Ethicon Endo-Surgery, Inc. · Nov 2014
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
K140560 · Ethicon Endo-Surgery, LLC · Apr 2014
RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
K140609 · Covidien · Apr 2014
ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY
K133938 · Covidien · Jan 2014
ENDO GIA(TM) EXTRA LONG ADAPTER
K133762 · Covidien, LLC · Jan 2014
OPTIFIX ABSORBABLE FIXATION SYSTEM
K132134 · C.R. Bard, Inc. · Dec 2013