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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 284
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K003522.
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45
K012809 · Power Medical Interventions, Inc. · Oct 2001
MODIFICATION TO VASCULAR CLOSURE DEVICE
K012362 · Std Mfg., Inc. · Aug 2001
TISSUE MARKER
K001807 · Advanced Uroscience, Inc. · May 2001
SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33
K003277 · Powermed, Inc. · Dec 2000
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc · Dec 2000
VASCULAR CLOSURE DEVICE
K003169 · Std Mfg., Inc. · Dec 2000
K003522 · SALUTE
Download PDF FDA Summary Onux Medical, Inc.