Cleared Abbreviated

K162617 - NobleStitch EL

K162617 is an FDA 510(k) clearance for NobleStitch EL, manufactured by Nobles Medical Technologies Ii, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Abbreviated 510(k) pathway after a 198-day FDA review.

K162617 · 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
Apr 2017
Decision
198d
Days
Class 2
Risk

K162617 is an FDA 510(k) clearance for the NobleStitch EL. 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 April 6, 2017 after a review of 198 days - an extended review 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 - K162617

510(k) Number K162617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received September 20, 2016
Decision Date April 06, 2017
Days to Decision 198 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 115d · This submission: 198d
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 80
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K162617.
Gazelle Polypropylene Suture and Delivery Device
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MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL
K143582 · Resorba Medical GmbH · Oct 2015
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K151112 · Angiotech · Sep 2015