Cleared Special

K062729 - SURGISIS RVP RECTO-VAGINAL FISTULA PLUG

K062729 is the FDA 510(k) clearance for SURGISIS RVP RECTO-VAGINAL FISTULA PLUG by Cook Biotech, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTM) cleared through the Special 510(k) pathway after a 27-day FDA review.

K062729 · Cook Biotech, Inc. · General & Plastic Surgery device
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Oct 2006
Decision
27d
Days
Class 2
Risk

K062729 is an FDA 510(k) clearance for the SURGISIS RVP RECTO-VAGINAL FISTULA PLUG. 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 10, 2006 after a review of 27 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cook Biotech, Inc. devices

Submission Details

510(k) Number K062729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2006
Decision Date October 10, 2006
Days to Decision 27 days
Submission Type Special
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
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K062729.
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