Cleared Traditional

K160705 - Y.JACOBS YOUNG'S THREAD Synthetic Absor...

K160705 is an FDA 510(k) clearance for Y.JACOBS YOUNG'S THREAD Synthetic Absor..., 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 254-day FDA review.

K160705 · Y. Jacobs Medical, Inc. · General & Plastic Surgery device
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Nov 2016
Decision
254d
Days
Class 2
Risk

K160705 is an FDA 510(k) clearance for the Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,. 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 November 23, 2016 after a review of 254 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 - K160705

510(k) Number K160705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2016
Decision Date November 23, 2016
Days to Decision 254 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
139d slower than avg
Panel avg: 115d · This submission: 254d
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 K160705.
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STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES
K141776 · Ethicon, Inc. · Oct 2014
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