Cleared Traditional

K170166 - CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture

K170166 is an FDA 510(k) clearance for CARESORB-Polyglactin 910 Surgical Suture, manufactured by Cpt Sutures Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K170166 · Cpt Sutures Co., Ltd. · 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
253d
Days
Class 2
Risk

K170166 is an FDA 510(k) clearance for the CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast abso.... Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Cpt Sutures Co., Ltd. (Phu Thuan Ward District 7, VN). The FDA issued a Cleared decision on September 29, 2017 after a review of 253 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 - K170166

510(k) Number K170166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2017
Decision Date September 29, 2017
Days to Decision 253 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
138d slower than avg
Panel avg: 115d · This submission: 253d
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 Consultant

Mdi Consultants, Inc.
Natalya Valerio

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K170166.
REXMONO, PDREX
K173779 · Sm Eng Co., Ltd. · Mar 2018
Holycon Synthetic Absorbable Sutures
K173043 · Nantong Holycon Medical Devices Co., Ltd. · Dec 2017
Monosyn Quick Synthetic Absorbable Surgical Suture
K171001 · Aesculap, Inc. · Oct 2017
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 · M/s. Meril Endo Surgery Private Limited. · Sep 2017
Silhouette InstaLift
K163676 · Silhouette Lift, Inc. · Jun 2017
TroClose1200, TroClose1200 Cannula
K171494 · Gordian Surgical, Ltd. · Jun 2017