Cleared Traditional

NON-BIOABSORBABLE STAPLE (K023372) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023372 · Onux Medical, Inc. · General & Plastic Surgery device
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Dec 2002
Decision
80d
Days
Class 2
Risk

K023372 is an FDA 510(k) clearance for the NON-BIOABSORBABLE STAPLE. Classified as Suture, Nonabsorbable, Nitinol (product code NJU), Class II - Special Controls.

Submitted by Onux Medical, Inc. (Hampton, US). The FDA issued a Cleared decision on December 27, 2002 after a review of 80 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 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 Onux Medical, Inc. devices

Submission Details

510(k) Number K023372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2002
Decision Date December 27, 2002
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NJU Suture, Nonabsorbable, Nitinol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
Definition Soft Tissue Approximation.
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.