Cleared Traditional

K161633 - REXLON, REXSIL

K161633 is an FDA 510(k) clearance for REXLON, manufactured by Sm Eng Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K161633 · Sm Eng Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
262d
Days
Class 2
Risk

K161633 is an FDA 510(k) clearance for the REXLON, REXSIL. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Sm Eng Co., Ltd. (Sasang-Gu, KR). The FDA issued a Cleared decision on March 2, 2017 after a review of 262 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - 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 - K161633

510(k) Number K161633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2016
Decision Date March 02, 2017
Days to Decision 262 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
147d slower than avg
Panel avg: 115d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 33
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K161633.
Golnit Nylon Monofilament Suture
K212888 · Antarma, LLC Dba Golnit Sutures · Mar 2022
Non Absorbable Surgical Nylon Suture
K212603 · Shandong Haidike Medical Product Co., Ltd. · Dec 2021
Crownjun Nylon Suture
K192420 · Kono Seisakusho Co., Ltd. · May 2020
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
K151165 · Aesculap, Inc. · Feb 2016
RiverLon (Nylon) Suture
K152795 · Riverpoint Medical · Oct 2015
VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
K123034 · Unilene Sac · May 2013