Cleared Abbreviated

K030351 - STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K030351 · Cp Medical · General & Plastic Surgery device
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Mar 2003
Decision
53d
Days
Class 2
Risk

K030351 is an FDA 510(k) clearance for the STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Cp Medical (Portland, US). The FDA issued a Cleared decision on March 28, 2003 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4495 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cp Medical devices

Submission Details

510(k) Number K030351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2003
Decision Date March 28, 2003
Days to Decision 53 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 114d · This submission: 53d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
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.