Cleared Special

K012865 - SUPERSTITCH VASCULAR SUTURING DEVICE

K012865 is an FDA 510(k) clearance for SUPERSTITCH VASCULAR SUTURING DEVICE, manufactured by Sutura, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Special 510(k) pathway after a 29-day FDA review.

K012865 · Sutura, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
29d
Days
Class 2
Risk

K012865 is an FDA 510(k) clearance for the SUPERSTITCH VASCULAR SUTURING DEVICE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Sutura, Inc. (Fountain Valley, US). The FDA issued a Cleared decision on September 25, 2001 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - 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 Sutura, Inc. devices

FDA 510(k) Submission Details - K012865

510(k) Number K012865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2001
Decision Date September 25, 2001
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 27
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K012865.
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890 · Aesculap, Inc. · Jul 2014
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · Ethicon, Inc. · Dec 2013
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · United States Surgical, A Division of Tyco Healthc · Jun 2005
AMS SLING FIXATION SYSTEM
K010990 · American Medical Systems, Inc. · Jun 2001
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · Ethicon, Inc. · Jul 2000
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
K001185 · Cp Medical · Jun 2000