Cleared Traditional

K003522 - SALUTE

K003522 is an FDA 510(k) clearance for SALUTE, manufactured by Onux Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K003522 · Onux Medical, Inc. · General & Plastic Surgery device
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Feb 2001
Decision
90d
Days
Class 2
Risk

K003522 is an FDA 510(k) clearance for the SALUTE. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Onux Medical, Inc. (Hampton, US). The FDA issued a Cleared decision on February 13, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Onux Medical, Inc. devices

FDA 510(k) Submission Details - K003522

510(k) Number K003522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2000
Decision Date February 13, 2001
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 227
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K003522.
ENDOANCHOR AND OPENANCHOR
K013749 · Ethicon Endo-Surgery, Inc. · Feb 2002
AUTO SUTURE SURGICAL STAPLES
K013860 · United States Surgical, A Division of Tyco Healthc · Dec 2001
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45
K012809 · Power Medical Interventions, Inc. · Oct 2001
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc · Dec 2000
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
K000060 · Senorx, Inc. · Mar 2000
ULTRACLIP TISSUE MARKER
K993785 · Inrad · Feb 2000