Cleared Traditional

K161629 - CRYLREX

K161629 is the FDA 510(k) clearance for CRYLREX by Sm Eng Co., Ltd.. It is a Class 2 General & Plastic Surgery device (product code GAM) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K161629 · Sm Eng Co., Ltd. · General & Plastic Surgery device
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Feb 2017
Decision
242d
Days
Class 2
Risk

K161629 is an FDA 510(k) clearance for the CRYLREX. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Sm Eng Co., Ltd. (Sasang-Gu, KR). The FDA issued a Cleared decision on February 10, 2017 after a review of 242 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.

View all Sm Eng Co., Ltd. devices

Submission Details

510(k) Number K161629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2016
Decision Date February 10, 2017
Days to Decision 242 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 115d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K161629.
REXMONO, PDREX
K173779 · Sm Eng Co., Ltd. · Mar 2018
Monosyn Quick Synthetic Absorbable Surgical Suture
K171001 · Aesculap, Inc. · Oct 2017
Novosyn Quick Absorbable Suture
K170661 · Aesculap, Inc. · Jun 2017
E-Pack Procedure Kit
K161726 · Ethicon, Inc. · Jul 2016
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
K151200 · Ethicon, Inc. · Aug 2015
PLIASURE Polyglycolide Synthetic Absorbable Suture
K142822 · Ethicon, Inc. · Mar 2015