Cleared Traditional

REXLON, REXSIL (K161633) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161633 · Sm Eng Co., Ltd. · General & Plastic Surgery device
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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

Submission Details

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
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.

Device Classification

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 Peers - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K161633.
Tissue Approximation System
K261484 · Tas Medical, Inc. · Jun 2026
Tissue Approximation System (TAS)
K220980 · Tas Medical, Inc. · Jul 2023
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