Cleared Special

K083537 - MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM

K083537 is an FDA 510(k) clearance for MODIFICATION TO MEDWAVES MICROWAVE COAG..., manufactured by Medwaves Incorporated. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Special 510(k) pathway after a 48-day FDA review.

K083537 · Medwaves Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
48d
Days
Class 2
Risk

K083537 is an FDA 510(k) clearance for the MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Medwaves Incorporated (San Diego, US). The FDA issued a Cleared decision on January 15, 2009 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K083537

510(k) Number K083537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2008
Decision Date January 15, 2009
Days to Decision 48 days
Submission Type Special
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
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Modification to existing cleared device.

NEY Device Classification - Class 2, Special Controls

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - NEY System, Ablation, Microwave And Accessories

All 67
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K083537.
HS AMICA
K083157 · H.S Hospital Service S.P.A · Sep 2009
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
K082819 · Miramar Labs, Inc. · Mar 2009
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200
K082565 · Microsurgeon, Inc. · Feb 2009
VALLEYLAB MICROWAVE ABLATION GENERATOR
K072687 · Covidien Lp, Formerly Know AS Valleylab, A Divison · Nov 2008
MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
K081042 · Bsd Medical Systems Corp. · Sep 2008
MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
K072870 · Foundry Newco X, Inc. · Jan 2008
K083537 · MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
Download PDF FDA Summary Medwaves Incorporated