Cleared Traditional

K141072 - SUPOLENE

K141072 is an FDA 510(k) clearance for SUPOLENE, manufactured by Resorba Medical GmbH. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K141072 · Resorba Medical GmbH · General & Plastic Surgery device
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Jun 2014
Decision
59d
Days
Class 2
Risk

K141072 is an FDA 510(k) clearance for the SUPOLENE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Resorba Medical GmbH (Nuremberg, DE). The FDA issued a Cleared decision on June 23, 2014 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 Resorba Medical GmbH devices

FDA 510(k) Submission Details - K141072

510(k) Number K141072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2014
Decision Date June 23, 2014
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 115d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 141
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K141072.
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2
K150327 · Dunamis, LLC · Jun 2015
Force Fiber OrthoTape suture
K150438 · Teleflexmedical, Inc. · Apr 2015
LARIAT sulture Delivery Device
K142241 · Sentreheart, Inc. · Sep 2014
A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
K133770 · Anchor Innovation Medical (A.I.M.) · Jun 2014
ARTHREX BIOSUTURE
K140019 · Arthrex, Inc. · Jan 2014
TFCC FAST-FIX KIT
K132079 · Smith & Nephew, Inc. · Dec 2013