Cleared Traditional

K153076 - silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL (FDA 510(k) Clearance)

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

K153076 · Teleflexmedical, Inc. · General & Plastic Surgery device
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Jun 2016
Decision
237d
Days
Class 2
Risk

K153076 is an FDA 510(k) clearance for the silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX.... Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on June 16, 2016 after a review of 237 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 Teleflexmedical, Inc. devices

Submission Details

510(k) Number K153076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2015
Decision Date June 16, 2016
Days to Decision 237 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
123d slower than avg
Panel avg: 114d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 172
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