Cleared Traditional

K012124 - MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP

K012124 is an FDA 510(k) clearance for MERSILK BLACK SILK BRAIDED NON-ABSORBAB..., manufactured by Johnson & Johnson Medical (China) , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K012124 · Johnson & Johnson Medical (China) , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
75d
Days
Class 2
Risk

K012124 is an FDA 510(k) clearance for the MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by Johnson & Johnson Medical (China) , Ltd. (Monhang, Shanghai, CN). The FDA issued a Cleared decision on September 19, 2001 after a review of 75 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 Johnson & Johnson Medical (China) , Ltd. devices

FDA 510(k) Submission Details - K012124

510(k) Number K012124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2001
Decision Date September 19, 2001
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 115d · This submission: 75d
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 24
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K012124.
SILK Surgical Suture
K162396 · Teleflexmedical, Inc. · Nov 2016
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture
K160623 · M/s. Meril Endo Surgery Private Limited. · May 2016
NON-ABSORBABLE SILK SUTURE
K071111 · Arrow Intl., Inc. · Jul 2007
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
K001184 · Cp Medical · Jun 2000
SUTRASILK SILK SUTURE
K994177 · Visionary Medical Supplies, Inc. · Feb 2000
SILK
K993999 · Trading Consultants and Distributors Intl., Inc. · Feb 2000