Cleared Traditional

K173779 - REXMONO, PDREX

K173779 is an FDA 510(k) clearance for REXMONO, manufactured by Sm Eng 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 90-day FDA review.

K173779 · Sm Eng Co., Ltd. · General & Plastic Surgery device
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Mar 2018
Decision
90d
Days
Class 2
Risk

K173779 is an FDA 510(k) clearance for the REXMONO, PDREX. 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 March 12, 2018 after a review of 90 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K173779

510(k) Number K173779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2017
Decision Date March 12, 2018
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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

Wise Company, Inc.
Sanglok Lee

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 122
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K173779.
Caprolon
K181320 · Resorba Medical GmbH · Sep 2018
Rondek PGA Suture (Beige or Violet)
K180625 · Rk Manufacturing Corporation · May 2018
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
K173874 · Origami Surgical, LLC · May 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
CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture
K170166 · Cpt Sutures Co., Ltd. · Sep 2017