Cleared Special

K070738 - SIS FACIAL CYLINDER, SIS FACIAL IMPLANT

K070738 is an FDA 510(k) clearance for SIS FACIAL CYLINDER, manufactured by Cook Biotech, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Special 510(k) pathway after a 20-day FDA review.

K070738 · Cook Biotech, Inc. · General & Plastic Surgery device
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Apr 2007
Decision
20d
Days
Class 2
Risk

K070738 is an FDA 510(k) clearance for the SIS FACIAL CYLINDER, SIS FACIAL IMPLANT. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on April 5, 2007 after a review of 20 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

FDA 510(k) Submission Details - K070738

510(k) Number K070738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2007
Decision Date April 05, 2007
Days to Decision 20 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

FTM Device Classification - Class 2, Special Controls

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 133
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K070738.
MESOSFOL SURGICAL FILM
K062558 · Biomet Manufacturing Corp · Jun 2007
LRTM SURGICAL MESH
K070560 · Lifecell Corp. · Jun 2007
ORTHADAPT BIOIMPLANT
K071065 · Pegasus Biologics, Inc. · May 2007
PERIPATCH ENDO-SLEEVE
K063556 · Pm Devices, Inc. · Mar 2007
VERITAS COLLAGEN MATRIX
K062915 · Synovis Surgical Innovations · Dec 2006
PROPATCH SOFT TISSUE REPAIR MATRIX
K061892 · Cryolife, Inc. · Nov 2006