Cleared Traditional

AUTO SUTUR ENDO GIA STAPLERS (K061095) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 106
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K061095.
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
K082396 · C.R. Bard, Inc. · Jan 2009
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · United States Surgical, A Division of Tyco Healthc · Sep 2007
AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
K062850 · United States Surgical, A Division of Tyco Healthc · Oct 2006
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
K032696 · United States Surgical, A Division of Tyco Healthc · Dec 2003
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K024275 · United States Surgical, A Division of Tyco Healthc · Mar 2003
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · United States Surgical, A Division of Tyco Healthc · Nov 2002