Cleared Abbreviated

ORLON NONABSORABLE SURGICAL SUTURE USP (K030177) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 11
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K030177.
Crownjun Nylon Suture
K192420 · Kono Seisakusho Co., Ltd. · May 2020
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
K151165 · Aesculap, Inc. · Feb 2016
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
K990090 · Aesculap, Inc. · Mar 1999
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*
K904931 · United States Surgical, A Division of Tyco Healthc · Jan 1991
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
K905379 · United States Surgical, A Division of Tyco Healthc · Jan 1991