Cleared Traditional

K143584 - PGA RESORBA, PGA RESOQUICK, GLYCOLON

K143584 is an FDA 510(k) clearance for PGA RESORBA, manufactured by Resorba Medical GmbH. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K143584 · Resorba Medical GmbH · General & Plastic Surgery device
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Nov 2015
Decision
319d
Days
Class 2
Risk

K143584 is an FDA 510(k) clearance for the PGA RESORBA, PGA RESOQUICK, GLYCOLON. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Resorba Medical GmbH (Nuremberg, DE). The FDA issued a Cleared decision on November 2, 2015 after a review of 319 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 878.4493 - 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

FDA 510(k) Submission Details - K143584

510(k) Number K143584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2014
Decision Date November 02, 2015
Days to Decision 319 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 115d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 122
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K143584.
TroClose1200
K160564 · Gordian Surgical, Ltd. · Nov 2016
E-Pack Procedure Kit
K161726 · Ethicon, Inc. · Jul 2016
Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
K153611 · Ethicon, LLC · Jun 2016
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
K150717 · M/s. Meril Endo Surgery Private Limited. · Oct 2015
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
K151200 · Ethicon, Inc. · Aug 2015
SILHOUETTE INSTALIFT
K142061 · Silhouette Lift, Inc. · Apr 2015