Cleared Traditional

K030158 - UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED

K030158 is an FDA 510(k) clearance for UNIT, manufactured by Walsh Medical Devices, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K030158 · Walsh Medical Devices, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
182d
Days
Class 2
Risk

K030158 is an FDA 510(k) clearance for the UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Walsh Medical Devices, Inc. (Oakville, Ontario, CA). The FDA issued a Cleared decision on July 17, 2003 after a review of 182 days - an extended review 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. 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.

View all Walsh Medical Devices, Inc. devices

FDA 510(k) Submission Details - K030158

510(k) Number K030158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2003
Decision Date July 17, 2003
Days to Decision 182 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1668
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K030158.
COBRA COOLED SURGICAL PROBE, MODEL M004159670
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MODIFICATION TO THERMACOOL TC SYSTEM
K032088 · Thermage, Inc. · Aug 2003
CARDIOVATIONS OPTICAL BIPOLAR DEVICE
K031846 · Ethicon, Inc. · Jul 2003
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
K031247 · Medtronic Vascular · Jul 2003
BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD
K031950 · Baylis Medical Co., Inc. · Jul 2003
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
K031675 · Smith & Nephew, Inc. · Jun 2003