Cleared Traditional

K061095 - AUTO SUTUR ENDO GIA STAPLERS

K061095 is an FDA 510(k) clearance for AUTO SUTUR ENDO GIA STAPLERS, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K061095 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
42d
Days
Class 2
Risk

K061095 is an FDA 510(k) clearance for the AUTO SUTUR ENDO GIA STAPLERS. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on May 31, 2006 after a review of 42 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K061095

510(k) Number K061095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2006
Decision Date May 31, 2006
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 115d · This submission: 42d
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 251
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K061095.
INSORB ABSORBABLE STAPLE, MODEL 1020
K061784 · Incisive Surgical, Inc. · Jul 2006
EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
K060494 · Medchannel, LLC · Jul 2006
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
K061156 · Ethicon Endo-Surgery, Inc. · Jul 2006
CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
K053631 · Ethicon Endo-Surgery, Inc. · Jan 2006
POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS
K052910 · Power Medical Interventions, Inc. · Nov 2005
POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS
K052415 · Power Medical Interventions, Inc. · Sep 2005