Cleared Traditional

K001184 - SILK, NONABSORBABLE, SURGICAL SUTURES, USP

K001184 is an FDA 510(k) clearance for SILK, manufactured by Cp Medical. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K001184 · Cp Medical · General & Plastic Surgery device
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Jun 2000
Decision
73d
Days
Class 2
Risk

K001184 is an FDA 510(k) clearance for the SILK, NONABSORBABLE, SURGICAL SUTURES, USP. Classified as Suture, Nonabsorbable, Silk (product code GAP), 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 878.5030 - 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 - K001184

510(k) Number K001184 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.

GAP Device Classification - Class 2, Special Controls

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
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 - GAP Suture, Nonabsorbable, Silk

All 27
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K001184.
MANI NEEDLE & SUTURE PACK (SILK)
K053638 · Mani, Inc. · May 2006
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
K041514 · Sutures India Private Limited · Jun 2005
UNISILK
K042282 · United Medical Industries Co. , Ltd. · Dec 2004
SUTRASILK SILK SUTURE
K994177 · Visionary Medical Supplies, Inc. · Feb 2000
SILK
K993999 · Trading Consultants and Distributors Intl., Inc. · Feb 2000
SILK SUTURE
K982853 · Davis & Geck, Inc. · Apr 1999