Cleared Traditional

K160705 - Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, (FDA 510(k) Clearance)

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

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

Submission Details

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
140d slower than avg
Panel avg: 114d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 61
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K160705.
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