Cleared Special

K172149 - FILASILK - Natural Non-absorbable Silk ...

K172149 is the FDA 510(k) clearance for FILASILK - Natural Non-absorbable Silk ... by M/s. Meril Endo Surgery Private Limited.. It is a Class 2 General & Plastic Surgery device (product code GAP) cleared through the Special 510(k) pathway after a 95-day FDA review.

K172149 · M/s. Meril Endo Surgery Private Limited. · General & Plastic Surgery device
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Oct 2017
Decision
95d
Days
Class 2
Risk

K172149 is an FDA 510(k) clearance for the FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorb.... Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on October 20, 2017 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5030 - 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. Standard predicate reliance. 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 K172149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2017
Decision Date October 20, 2017
Days to Decision 95 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
20d faster than avg
Panel avg: 115d · This submission: 95d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
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 - GAP Suture, Nonabsorbable, Silk

All 18
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K172149.
Non absorbable Surgical Silk Suture
K232355 · Shandong Haidike Medical Product Co., Ltd. · Jan 2024
Surgical Sutures with or without Needle
K221767 · Huaian Seamen Medical Technology Co., Ltd. · Jul 2023
SafePath Suturing System
K180701 · Safepath Medical, Inc. · Jun 2018
SILK Surgical Suture
K162396 · Teleflexmedical, Inc. · Nov 2016
NON-ABSORBABLE SILK SUTURE
K071111 · Arrow Intl., Inc. · Jul 2007
SILK SUTURE
K982853 · Davis & Geck, Inc. · Apr 1999