Cleared Traditional

K023843 - SMARTSTITCH M-CONNECTOR, MODEL OM-8005 (FDA 510(k) Clearance)

Also includes:
SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500 AND SMARTSTITCH SUTURE CARTRIDGE

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023843 · Opus Medical, Inc. · Gastroenterology & Urology device
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Feb 2003
Decision
88d
Days
Class 2
Risk

K023843 is an FDA 510(k) clearance for the SMARTSTITCH M-CONNECTOR, MODEL OM-8005. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Opus Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on February 14, 2003 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Opus Medical, Inc. devices

Submission Details

510(k) Number K023843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2002
Decision Date February 14, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.