Cleared Traditional

K082518 - DUAL NEEDLE SUTURE PASSER SYSTEM

K082518 is an FDA 510(k) clearance for DUAL NEEDLE SUTURE PASSER 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 136-day FDA review.

K082518 · Cayenne Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
136d
Days
Class 2
Risk

K082518 is an FDA 510(k) clearance for the DUAL NEEDLE SUTURE PASSER SYSTEM. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Cayenne Medical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on January 16, 2009 after a review of 136 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.

FDA 510(k) Submission Details - K082518

510(k) Number K082518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date January 16, 2009
Days to Decision 136 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
21d slower than avg
Panel avg: 115d · This submission: 136d
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 175
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K082518.
LARIAT II SUTURE DELIVERY DEVICE
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COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE
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TAC-TITE (TM)
K090128 · Core Essence Orthopaedics, Inc. · Mar 2009
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
K082535 · Surgical Devices, A Global Business Unit Covidien · Dec 2008
MENISCAL CINCH
K073149 · Arthrex, Inc. · Feb 2008
ANCHORAGE CLOSURE DEVICE
K073096 · Epitek, Inc. · Feb 2008
K082518 · DUAL NEEDLE SUTURE PASSER SYSTEM
Download PDF FDA Summary Cayenne Medical, Inc.