Cleared Special

K172659 - MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture

K172659 is an FDA 510(k) clearance for MEGASORB - Natural absorbable Polyglyco..., manufactured by M/s. Meril Endo Surgery Private Limited.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Special 510(k) pathway after a 23-day FDA review.

K172659 · M/s. Meril Endo Surgery Private Limited. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
23d
Days
Class 2
Risk

K172659 is an FDA 510(k) clearance for the MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Abso.... Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on September 28, 2017 after a review of 23 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K172659

510(k) Number K172659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2017
Decision Date September 28, 2017
Days to Decision 23 days
Submission Type Special
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
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 149
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K172659.
Holycon Synthetic Absorbable Sutures
K173043 · Nantong Holycon Medical Devices Co., Ltd. · Dec 2017
Monosyn Quick Synthetic Absorbable Surgical Suture
K171001 · Aesculap, Inc. · Oct 2017
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
K170166 · Cpt Sutures Co., Ltd. · Sep 2017
Silhouette InstaLift
K163676 · Silhouette Lift, Inc. · Jun 2017
TroClose1200, TroClose1200 Cannula
K171494 · Gordian Surgical, Ltd. · Jun 2017
Novosyn Quick Absorbable Suture
K170661 · Aesculap, Inc. · Jun 2017
K172659 · MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
Download PDF FDA Summary M/s. Meril Endo Surge…