Cleared Traditional

MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP (K012124) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012124 · Johnson & Johnson Medical (China) , Ltd. · General & Plastic Surgery device
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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

Submission Details

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.

Device Classification

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 11
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K012124.
Non absorbable Surgical Silk Suture
K232355 · Shandong Haidike Medical Product Co., Ltd. · Jan 2024
Surgical Sutures with or without Needle
K221767 · Huaian Seamen Medical Technology Co., Ltd. · Jul 2023
SafePath Suturing System
K180701 · Safepath Medical, Inc. · Jun 2018
SILKAM NONABSORBABLE SILK SURGICAL SUTURE
K990089 · Aesculap, Inc. · Mar 1999
SOFSILK SUTURE
K981128 · United States Surgical, A Division of Tyco Healthc · May 1998
SOFSILK SUTURE
K980124 · United States Surgical, A Division of Tyco Healthc · Mar 1998