Cleared Special

K013860 - AUTO SUTURE SURGICAL STAPLES

K013860 is the FDA 510(k) clearance for AUTO SUTURE SURGICAL STAPLES 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.

K013860 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
28d
Days
Class 2
Risk

K013860 is an FDA 510(k) clearance for the AUTO SUTURE SURGICAL STAPLES. 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 December 19, 2001 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 K013860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2001
Decision Date December 19, 2001
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 K013860.
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K020804 · United States Surgical, A Division of Tyco Healthc · Nov 2002
PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
K020779 · Ethicon Endo-Surgery, Inc. · Jun 2002
ENDOANCHOR AND OPENANCHOR
K013749 · Ethicon Endo-Surgery, Inc. · Feb 2002
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc · Dec 2000
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
K000060 · Senorx, Inc. · Mar 2000
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K991030 · Ethicon Endo-Surgery, Inc. · May 1999