Cleared Traditional

PROXIFAST ABSORBABLE STAPLE (K132669) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132669 · Surgimatix, Inc. · General & Plastic Surgery device
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Jan 2014
Decision
139d
Days
Class 2
Risk

K132669 is an FDA 510(k) clearance for the PROXIFAST ABSORBABLE STAPLE. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Surgimatix, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on January 13, 2014 after a review of 139 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. 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 Surgimatix, Inc. devices

Submission Details

510(k) Number K132669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2013
Decision Date January 13, 2014
Days to Decision 139 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
24d slower than avg
Panel avg: 115d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K132669.
ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
K141952 · Ethicon Endo-Surgery, Inc. · Nov 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
OPTIFIX ABSORBABLE FIXATION SYSTEM
K132134 · C.R. Bard, Inc. · Dec 2013
ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
K123114 · Ethicon, Inc. · Feb 2013
PERMASORB DISPOSABLE FIXATION DEVICE
K123718 · C.R. Bard, Inc. · Jan 2013