Cleared Traditional

K072687 - VALLEYLAB MICROWAVE ABLATION GENERATOR

K072687 is an FDA 510(k) clearance for VALLEYLAB MICROWAVE ABLATION GENERATOR, manufactured by Covidien Lp, Formerly Know AS Valleylab, A Divison. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K072687 · Covidien Lp, Formerly Know AS Valleylab, A Divison · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
428d
Days
Class 2
Risk

K072687 is an FDA 510(k) clearance for the VALLEYLAB MICROWAVE ABLATION GENERATOR. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by Covidien Lp, Formerly Know AS Valleylab, A Divison (Boulder, US). The FDA issued a Cleared decision on November 25, 2008 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

FDA 510(k) Submission Details - K072687

510(k) Number K072687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date November 25, 2008
Days to Decision 428 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
313d slower than avg
Panel avg: 115d · This submission: 428d
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 K072687.
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
K082819 · Miramar Labs, Inc. · Mar 2009
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200
K082565 · Microsurgeon, Inc. · Feb 2009
MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
K083537 · Medwaves Incorporated · Jan 2009
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
MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
K070356 · Medwaves Incorporated · Dec 2007
K072687 · VALLEYLAB MICROWAVE ABLATION GENERATOR
Download PDF FDA Summary Covidien Lp, Formerly…