Cleared Abbreviated

K030177 - ORLON NONABSORABLE SURGICAL SUTURE USP

K030177 is an FDA 510(k) clearance for ORLON NONABSORABLE SURGICAL SUTURE USP, manufactured by Sri Orion Pharmaceuticals & Sutures. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Abbreviated 510(k) pathway after a 185-day FDA review.

K030177 · Sri Orion Pharmaceuticals & Sutures · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
185d
Days
Class 2
Risk

K030177 is an FDA 510(k) clearance for the ORLON NONABSORABLE SURGICAL SUTURE USP. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Sri Orion Pharmaceuticals & Sutures (Potomac, US). The FDA issued a Cleared decision on July 21, 2003 after a review of 185 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - 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.

View all Sri Orion Pharmaceuticals & Sutures devices

FDA 510(k) Submission Details - K030177

510(k) Number K030177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2003
Decision Date July 21, 2003
Days to Decision 185 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
70d slower than avg
Panel avg: 115d · This submission: 185d
Pathway characteristics
Standards-based clearance path.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 29
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K030177.
RiverLon (Nylon) Suture
K152795 · Riverpoint Medical · Oct 2015
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
K123034 · Unilene Sac · May 2013
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
NYLON, NONABSORBABLE SURGICAL SUTURES USP
K001173 · Cp Medical · Jun 2000
MICRINS MICROSURGICAL SUTURE
K993970 · Micrins Surgical, Inc. · Mar 2000
SUTRALON NYLON SUTURES
K994176 · Visionary Medical Supplies, Inc. · Feb 2000