Cleared Traditional

K081042 - MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES

K081042 is an FDA 510(k) clearance for MICROTHERMX-100 MICROWAVE ABLATION SYST..., manufactured by Bsd Medical Systems Corp.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K081042 · Bsd Medical Systems Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
145d
Days
Class 2
Risk

K081042 is an FDA 510(k) clearance for the MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Bsd Medical Systems Corp. (Salt Lake City, US). The FDA issued a Cleared decision on September 3, 2008 after a review of 145 days - within the typical 510(k) review window.

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. 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 - K081042

510(k) Number K081042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2008
Decision Date September 03, 2008
Days to Decision 145 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
30d slower than avg
Panel avg: 115d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K081042.
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K070356 · Medwaves Incorporated · Dec 2007
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100
K070023 · Microsurgeon, Inc. · Aug 2007
K081042 · MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
Download PDF FDA Summary Bsd Medical Systems C…