Cleared Traditional

K070918 - 4DDOME

K070918 is an FDA 510(k) clearance for 4DDOME, manufactured by Cousin Biotech. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K070918 · Cousin Biotech · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
142d
Days
Class 2
Risk

K070918 is an FDA 510(k) clearance for the 4DDOME. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Cousin Biotech (Bonita Springs, US). The FDA issued a Cleared decision on August 22, 2007 after a review of 142 days - within the typical 510(k) review window.

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 Cousin Biotech devices

FDA 510(k) Submission Details - K070918

510(k) Number K070918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2007
Decision Date August 22, 2007
Days to Decision 142 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
27d slower than avg
Panel avg: 115d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
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 - FTL Mesh, Surgical, Polymeric

All 227
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K070918.
KENSEY NASH MACROPORE SHIELD
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TEPHAFLEX SURGICAL FILM
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IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
K071470 · Implantech Associates, Inc. · Aug 2007
PARIETEX POLYESTER MESH WITH INTRODUCER
K071629 · Sofradim Production · Jul 2007
MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM
K070846 · Prosurg, Inc. · Jul 2007
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
K071249 · Ethicon, Inc. · Jun 2007