Cleared Traditional

K072870 - MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)

K072870 is an FDA 510(k) clearance for MICROWAVE TISSUE COAGULATION SYSTEM (MTCS), manufactured by Foundry Newco X, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K072870 · Foundry Newco X, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
97d
Days
Class 2
Risk

K072870 is an FDA 510(k) clearance for the MICROWAVE TISSUE COAGULATION SYSTEM (MTCS). Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Foundry Newco X, Inc. (Menlo Park, US). The FDA issued a Cleared decision on January 14, 2008 after a review of 97 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 - K072870

510(k) Number K072870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2007
Decision Date January 14, 2008
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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 K072870.
MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
K083537 · Medwaves Incorporated · Jan 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
MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
K070356 · Medwaves Incorporated · Dec 2007
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100
K070023 · Microsurgeon, Inc. · Aug 2007
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
K061865 · Guidant Corp. · Jul 2006
K072870 · MICROWAVE TISSUE COAGULATION SYSTEM (MTCS)
Download PDF FDA Summary Foundry Newco X, Inc.