Cleared Traditional

K001173 - NYLON, NONABSORBABLE SURGICAL SUTURES USP

K001173 is an FDA 510(k) clearance for NYLON, manufactured by Cp Medical. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K001173 · Cp Medical · General & Plastic Surgery device
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Jun 2000
Decision
73d
Days
Class 2
Risk

K001173 is an FDA 510(k) clearance for the NYLON, NONABSORBABLE SURGICAL SUTURES USP. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Cp Medical (Portland, US). The FDA issued a Cleared decision on June 23, 2000 after a review of 73 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.

View all Cp Medical devices

FDA 510(k) Submission Details - K001173

510(k) Number K001173 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 11, 2000
Decision Date June 23, 2000
Days to Decision 73 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 115d · This submission: 73d
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 36
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K001173.
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
K041510 · Sutures India Private Limited · Jun 2005
UNIMIDE
K042284 · United Medical Industries Co. , Ltd. · Dec 2004
NYLON THREADED NEEDLE
K042367 · Aros Surgical Instruments Corp. · Oct 2004
MICRINS MICROSURGICAL SUTURE
K993970 · Micrins Surgical, Inc. · Mar 2000
SUTRALON NYLON SUTURES
K994176 · Visionary Medical Supplies, Inc. · Feb 2000
NYLON
K993998 · Trading Consultants and Distributors Intl., Inc. · Feb 2000