Cleared Traditional

K071796 - CAPSEW PLICATION SYSTEM

K071796 is an FDA 510(k) clearance for CAPSEW PLICATION SYSTEM, manufactured by Cayenne Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K071796 · Cayenne Medical, Inc. · General & Plastic Surgery device
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Oct 2007
Decision
109d
Days
Class 2
Risk

K071796 is an FDA 510(k) clearance for the CAPSEW PLICATION SYSTEM. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Cayenne Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on October 19, 2007 after a review of 109 days - within the typical 510(k) review window.

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 Cayenne Medical, Inc. devices

FDA 510(k) Submission Details - K071796

510(k) Number K071796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date October 19, 2007
Days to Decision 109 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
6d faster than avg
Panel avg: 115d · This submission: 109d
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 141
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K071796.
DUAL NEEDLE SUTURE PASSER SYSTEM
K082518 · Cayenne Medical, Inc. · Jan 2009
MENISCAL CINCH
K073149 · Arthrex, Inc. · Feb 2008
NEOTRACT ANCHOR SYSTEM
K073651 · Neotract, Inc. · Feb 2008
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
K072322 · Smith & Nephew, Inc. · Sep 2007
AXYA SUTURE WELDING SYSTEM AND KIT
K070253 · Axya Medical, Inc. · Jul 2007
ARTHREX FIBERWIRE
K071622 · Arthrex, Inc. · Jul 2007