Cleared Traditional

K060367 - TENOLIG

K060367 is an FDA 510(k) clearance for TENOLIG, manufactured by Fournitures Hospitalieres Industrie. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K060367 · Fournitures Hospitalieres Industrie · General & Plastic Surgery device
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Aug 2006
Decision
177d
Days
Class 2
Risk

K060367 is an FDA 510(k) clearance for the TENOLIG. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Fournitures Hospitalieres Industrie (Quimper Finistere, FR). The FDA issued a Cleared decision on August 9, 2006 after a review of 177 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 Fournitures Hospitalieres Industrie devices

FDA 510(k) Submission Details - K060367

510(k) Number K060367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2006
Decision Date August 09, 2006
Days to Decision 177 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 115d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

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 166
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