Cleared Special

K172659 - MEGASORB - Natural absorbable Polyglyco...

K172659 is the FDA 510(k) clearance for MEGASORB - Natural absorbable Polyglyco... by M/s. Meril Endo Surgery Private Limited.. It is a Class 2 General & Plastic Surgery device (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
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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.

View all M/s. Meril Endo Surgery Private Limited. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 75
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