Cleared Traditional

K020146 - SERRALNYL

K020146 is an FDA 510(k) clearance for SERRALNYL, manufactured by Serral, S.A. DE C.V.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K020146 · 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
89d
Days
Class 2
Risk

K020146 is an FDA 510(k) clearance for the SERRALNYL. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Serral, S.A. DE C.V. (Williamsburg, US). The FDA issued a Cleared decision on April 15, 2002 after a review of 89 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 Serral, S.A. DE C.V. devices

FDA 510(k) Submission Details - K020146

510(k) Number K020146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2002
Decision Date April 15, 2002
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
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 29
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K020146.
RiverLon (Nylon) Suture
K152795 · Riverpoint Medical · Oct 2015
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
K123034 · Unilene Sac · May 2013
AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE
K060528 · Aesculap, Inc. · Mar 2006
NYLON, NONABSORBABLE SURGICAL SUTURES USP
K001173 · Cp Medical · Jun 2000
MICRINS MICROSURGICAL SUTURE
K993970 · Micrins Surgical, Inc. · Mar 2000
SUTRALON NYLON SUTURES
K994176 · Visionary Medical Supplies, Inc. · Feb 2000