Cleared Traditional

K142822 - PLIASURE Polyglycolide Synthetic Absorbable Suture

K142822 is an FDA 510(k) clearance for PLIASURE Polyglycolide Synthetic Absorb..., manufactured by Ethicon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K142822 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
177d
Days
Class 2
Risk

K142822 is an FDA 510(k) clearance for the PLIASURE Polyglycolide Synthetic Absorbable Suture. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Ethicon, Inc. (Sommerville, US). The FDA issued a Cleared decision on March 26, 2015 after a review of 177 days - an extended review cycle.

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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K142822

510(k) Number K142822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2014
Decision Date March 26, 2015
Days to Decision 177 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
62d slower than avg
Panel avg: 115d · This submission: 177d
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 148
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K142822.
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
WEGO-PGCL Absorbable Surgical Monofilament Suture
K142810 · Foosin Medical Supplies Inc., Ltd. · Nov 2014
POLYCRYL
K140039 · Aurolab · Sep 2014
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
K141778 · Surgical Specialties Corporation · Jul 2014
K142822 · PLIASURE Polyglycolide Synthetic Absorbable Suture
Download PDF FDA Summary Ethicon, Inc.