Cleared Traditional

K160761 - DW-1C

K160761 is an FDA 510(k) clearance for DW-1C, manufactured by Dongwon Medical Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K160761 · Dongwon Medical Co., Ltd. · General & Plastic Surgery device
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Nov 2016
Decision
246d
Days
Class 2
Risk

K160761 is an FDA 510(k) clearance for the DW-1C. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Dongwon Medical Co., Ltd. (Gwangju, KR). The FDA issued a Cleared decision on November 22, 2016 after a review of 246 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - 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 Dongwon Medical Co., Ltd. devices

FDA 510(k) Submission Details - K160761

510(k) Number K160761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2016
Decision Date November 22, 2016
Days to Decision 246 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
131d slower than avg
Panel avg: 115d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEW Device Classification - Class 2, Special Controls

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
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 - NEW Suture, Surgical, Absorbable, Polydioxanone

All 36
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K160761.
Miracu
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STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
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STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
K141776 · Ethicon, Inc. · Oct 2014
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
K120284 · Coloplast A/S · May 2012