Cleared Special

K062850 - AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS

K062850 is the FDA 510(k) clearance for AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS by United States Surgical, A Division of Tyco Healthc. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Special 510(k) pathway after a 28-day FDA review.

K062850 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
28d
Days
Class 2
Risk

K062850 is an FDA 510(k) clearance for the AUTOSUTURE CIRCULAR EEA SURGICAL 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 October 23, 2006 after a review of 28 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

Submission Details

510(k) Number K062850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2006
Decision Date October 23, 2006
Days to Decision 28 days
Submission Type Special
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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 159
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K062850.
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · United States Surgical, A Division of Tyco Healthc · Sep 2007
ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
K070887 · Ethicon Endo-Surgery, LLC · May 2007
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G
K062869 · Ethicon Endo-Surgery, LLC · Feb 2007
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
K061156 · Ethicon Endo-Surgery, Inc. · Jul 2006
AUTO SUTUR ENDO GIA STAPLERS
K061095 · United States Surgical, A Division of Tyco Healthc · May 2006
CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
K053631 · Ethicon Endo-Surgery, Inc. · Jan 2006