Cleared Special

K062244 - OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR

K062244 is an FDA 510(k) clearance for OPUS SMARTSTICH SUTURE DEVICE WITH PERF..., manufactured by Arthrocare Corp.. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Special 510(k) pathway after a 60-day FDA review.

K062244 · Arthrocare Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
60d
Days
Class 2
Risk

K062244 is an FDA 510(k) clearance for the OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Arthrocare Corp. (San Juan Capistrano, US). The FDA issued a Cleared decision on October 2, 2006 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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.

FDA 510(k) Submission Details - K062244

510(k) Number K062244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2006
Decision Date October 02, 2006
Days to Decision 60 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 131d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

OCW Device Classification - Class 2, Special Controls

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 70
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K062244.
MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM
K070352 · Mini Lap Technologies, Inc. · Apr 2007
MINI LAP INSTRUMENTS
K070686 · Mini Lap Technologies, Inc. · Apr 2007
ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
K062875 · Endogastric Solutions, Inc. · Mar 2007
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
K061770 · Ethicon Endo-Surgery, Inc. · Sep 2006
SMARTSTITCH M-CONNECTOR, MODEL OM-8700
K033317 · Opus Medical, Inc. · Dec 2003
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269 · Ethicon Endo-Surgery, Inc. · Dec 2003
K062244 · OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
Download PDF FDA Summary Arthrocare Corp.