Cleared Traditional

K020901 - SERRALSILK

K020901 is an FDA 510(k) clearance for SERRALSILK, manufactured by Serral, S.A. DE C.V.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K020901 · Serral, S.A. DE C.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
37d
Days
Class 2
Risk

K020901 is an FDA 510(k) clearance for the SERRALSILK. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by Serral, S.A. DE C.V. (Williamsburg, US). The FDA issued a Cleared decision on April 26, 2002 after a review of 37 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.

FDA 510(k) Submission Details - K020901

510(k) Number K020901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2002
Decision Date April 26, 2002
Days to Decision 37 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
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 40
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K020901.
UNISILK
K042282 · United Medical Industries Co. , Ltd. · Dec 2004
SILK SUTURES
K024091 · Aurolab · Feb 2003
DEMETECH SILK NONABSORBABLE SUTURE
K023029 · Demetech Corp. · Nov 2002
MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP
K012124 · Johnson & Johnson Medical (China) , Ltd. · Sep 2001
GRAMS SILK NONABSORBABLE SUTURE
K003001 · Gramsmed, LLC · Dec 2000
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
K001184 · Cp Medical · Jun 2000
K020901 · SERRALSILK
Download PDF Serral, S.A. DE C.V.