Not Cleared Post-NSE

DEN060003 - TEPHAFLEX ABSORBABLE SUTURE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN060003 · Tepha, Inc. · General & Plastic Surgery device
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Feb 2007
Decision
272d
Days
Class 2
Risk

DEN060003 is an FDA 510(k) submission (not cleared) for the TEPHAFLEX ABSORBABLE SUTURE. Classified as Suture, Recombinant Technology (product code NWJ), Class II - Special Controls.

Submitted by Tepha, Inc. (Cambridge, US). The FDA issued a Not Cleared (DENG) decision on February 8, 2007 after a review of 272 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4494 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 272 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Tepha, Inc. devices

Submission Details

510(k) Number DEN060003 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 12, 2006
Decision Date February 08, 2007
Days to Decision 272 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 114d · This submission: 272d
Pathway characteristics

Device Classification

Product Code NWJ Suture, Recombinant Technology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4494
Definition Intended For Use In Soft Tissue Approximation. Indicated For Use In General Soft Tissue Approximation And/or Ligation.
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.