Cleared Abbreviated

K070243 - SUTRALENE POLYPROPYLENE SUTURES

K070243 is an FDA 510(k) clearance for SUTRALENE POLYPROPYLENE SUTURES, manufactured by Visionary Medical Supplies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Abbreviated 510(k) pathway after a 82-day FDA review.

K070243 · Visionary Medical Supplies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
82d
Days
Class 2
Risk

K070243 is an FDA 510(k) clearance for the SUTRALENE POLYPROPYLENE SUTURES. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Visionary Medical Supplies, Inc. (Stoughton, US). The FDA issued a Cleared decision on April 17, 2007 after a review of 82 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K070243

510(k) Number K070243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2007
Decision Date April 17, 2007
Days to Decision 82 days
Submission Type Abbreviated
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
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Standards-based clearance path.

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 84
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K070243.
QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE
K113800 · Angiotech · Jan 2012
SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME
K100593 · Lsi Solutions, Inc. · Oct 2010
DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
K093112 · Coloplast Manufacturing Us, LLC · Feb 2010
NEOTRACT ANCHOR
K061700 · Neotract, Inc. · Oct 2006
KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
K060414 · Kmi Kolster Methods, Inc. · Oct 2006
SUPERSTITCH 5F, 12F, AND EL
K062125 · Sutura, Inc. · Oct 2006
K070243 · SUTRALENE POLYPROPYLENE SUTURES
Download PDF FDA Summary Visionary Medical Sup…