Cleared Traditional

K994176 - SUTRALON NYLON SUTURES

K994176 is an FDA 510(k) clearance for SUTRALON NYLON SUTURES, manufactured by Visionary Medical Supplies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K994176 · 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
Feb 2000
Decision
60d
Days
Class 2
Risk

K994176 is an FDA 510(k) clearance for the SUTRALON NYLON SUTURES. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Visionary Medical Supplies, Inc. (Washington, US). The FDA issued a Cleared decision on February 8, 2000 after a review of 60 days - a notably fast clearance 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K994176

510(k) Number K994176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1999
Decision Date February 08, 2000
Days to Decision 60 days
Submission Type Traditional
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
55d faster than avg
Panel avg: 115d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K994176.
NYLON, NONABSORBABLE SURGICAL SUTURES USP
K001173 · Cp Medical · Jun 2000
NYLON NONABSORBABLE SURGICAL SUTURES, USP
K000539 · Arc Medical Supplies (Beijing) Co, Ltd. · Apr 2000
MICRINS MICROSURGICAL SUTURE
K993970 · Micrins Surgical, Inc. · Mar 2000
NYLON
K993998 · Trading Consultants and Distributors Intl., Inc. · Feb 2000
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE
K990090 · Aesculap, Inc. · Mar 1999
SURGILON, DERMALON, & OPHTHALON
K981582 · Davis & Geck, Inc. · Jul 1998
K994176 · SUTRALON NYLON SUTURES
Download PDF FDA Summary Visionary Medical Sup…