Cleared Special

K113763 - SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE

K113763 is an FDA 510(k) clearance for SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE, manufactured by Nobles Medical Technologies Ii, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Special 510(k) pathway after a 86-day FDA review.

K113763 · Nobles Medical Technologies Ii, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
86d
Days
Class 2
Risk

K113763 is an FDA 510(k) clearance for the SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Nobles Medical Technologies Ii, Inc. (Fountain Valley, US). The FDA issued a Cleared decision on March 16, 2012 after a review of 86 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.

FDA 510(k) Submission Details - K113763

510(k) Number K113763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2011
Decision Date March 16, 2012
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 80
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