Cleared Traditional

K081099 - TEPHAFLEX ABSORBABLE SUTURE (FDA 510(k) Clearance)

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

K081099 · Tepha, Inc. · General & Plastic Surgery device
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Jul 2008
Decision
89d
Days
Class 2
Risk

K081099 is an FDA 510(k) clearance for the TEPHAFLEX ABSORBABLE SUTURE. Classified as Suture, Recombinant Technology (product code NWJ), Class II - Special Controls.

Submitted by Tepha, Inc. (Lexington, US). The FDA issued a Cleared decision on July 15, 2008 after a review of 89 days - a notably fast clearance cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tepha, Inc. devices

Submission Details

510(k) Number K081099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2008
Decision Date July 15, 2008
Days to Decision 89 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
25d faster than avg
Panel avg: 114d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.