MicroThermX Microwave Ablation System

Basic Information

• Brand Name: MicroThermX Microwave Ablation System
• Primary DI: 00810563020533
• Version / Model: MTX-180
• Catalog Number: MTX-180
• Company Name: ENDOCARE, INC.
• Labeler DUNS: 928955509
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-27
• Public Version: 3
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: e810a2e9-17a9-4c50-8b41-d838fb97619f

Device Description

MicroThermX Microwave Ablation System - Mobile Cart

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61287	Microwave ablation system generator	A mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, natural orifice or open surgery procedures to ablate tissue typically in the liver, lung, pancreas, kidney, and uterus (e.g., endometrial ablation).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810563020533	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141785	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -15 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -15 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 75 Percent (%) Relative Humidity