Cleared Traditional

K143582 - MOPYLEN

K143582 is the FDA 510(k) clearance for MOPYLEN by Resorba Medical GmbH. It is a Class 2 General & Plastic Surgery device (product code GAW) cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K143582 · Resorba Medical GmbH · General & Plastic Surgery device
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Oct 2015
Decision
315d
Days
Class 2
Risk

K143582 is an FDA 510(k) clearance for the MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Resorba Medical GmbH (Nuremberg, DE). The FDA issued a Cleared decision on October 29, 2015 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Resorba Medical GmbH devices

Submission Details

510(k) Number K143582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date October 29, 2015
Days to Decision 315 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
200d slower than avg
Panel avg: 115d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 26
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K143582.
REXLENE
K173747 · Sm Eng Co., Ltd. · Dec 2018
Aesculap Optilene Nonabsorbable Suture
K180321 · Aesculap, Inc. · Mar 2018
Gazelle Polypropylene Suture and Delivery Device
K173644 · Dura Tap, LLC · Feb 2018
EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM
K141206 · Edwards Lifesciences, LLC · Jan 2015
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890 · Aesculap, Inc. · Jul 2014
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · Ethicon, Inc. · Dec 2013