Cleared Traditional

K042031 - OPUS SPEEDSTITCH SUTURE DEVICE

K042031 is an FDA 510(k) clearance for OPUS SPEEDSTITCH SUTURE DEVICE, manufactured by Opus 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 83-day FDA review.

K042031 · Opus Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Oct 2004
Decision
83d
Days
Class 2
Risk

K042031 is an FDA 510(k) clearance for the OPUS SPEEDSTITCH SUTURE DEVICE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Opus Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on October 19, 2004 after a review of 83 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K042031

510(k) Number K042031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2004
Decision Date October 19, 2004
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
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 129
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K042031.
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ORTHOFIBER
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K041589 · Arthrex, Inc. · Aug 2004
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K041216 · Smith & Nephew, Inc. · Jun 2004