Cleared Traditional

K143413 - J+PRAS YOUNG'S Thread

K143413 is an FDA 510(k) clearance for J+PRAS YOUNG'S Thread, manufactured by Y. Jacobs Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K143413 · Y. Jacobs Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
287d
Days
Class 2
Risk

K143413 is an FDA 510(k) clearance for the J+PRAS YOUNG'S Thread. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Y. Jacobs Medical, Inc. (Seoul, KR). The FDA issued a Cleared decision on September 11, 2015 after a review of 287 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 Y. Jacobs Medical, Inc. devices

FDA 510(k) Submission Details - K143413

510(k) Number K143413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2014
Decision Date September 11, 2015
Days to Decision 287 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
172d slower than avg
Panel avg: 115d · This submission: 287d
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 K143413.
Miracu
K172602 · Feeltech Co., Ltd. · Nov 2018
DemeTECH DemeDIOX absorbable surgical suture
K181582 · Demetech Corporation · Aug 2018
Omega VL
K162366 · Ov World Co., Ltd. · Mar 2018
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device
K150670 · Ethicon, Inc. · Jul 2015
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