Cleared Traditional

K070405 - MODIFICATION TO SURGISIS SLR STAPLE LIN...

K070405 is the FDA 510(k) clearance for MODIFICATION TO SURGISIS SLR STAPLE LIN... by Cook Biotech, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTM) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K070405 · Cook Biotech, Inc. · General & Plastic Surgery device
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Oct 2007
Decision
247d
Days
Class 2
Risk

K070405 is an FDA 510(k) clearance for the MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Cook Biotech, Inc. (Lafeyette, US). The FDA issued a Cleared decision on October 17, 2007 after a review of 247 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - 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 Cook Biotech, Inc. devices

Submission Details

510(k) Number K070405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2007
Decision Date October 17, 2007
Days to Decision 247 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
132d slower than avg
Panel avg: 115d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTM Mesh, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - FTM Mesh, Surgical

All 58
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K070405.
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