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THERMEDX 37-5 ELECTROCAUTERY PROBES - Bph240

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102275

by Thermedx, LLC

Identifiers

510(k) Number
K102275 FDA 510(k)
FDA Product Code
GEI FDA 510(k)
Models / Variants
Mpj200 FDA 510(k)
Mpj210 FDA 510(k)
Mps220 FDA 510(k)
Mpn230 FDA 510(k)
Bph240 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Thermedx 37-5 Electrocautery Probes are electrosurgical devices designed for cutting and coagulation. These probes are classified under the product code GEI (General and Plastic Surgery Electrosurgical Devices) and are intended for use in urological, gynecological, laparoscopic, and general surgical procedures. They deliver controlled electrical energy to tissue, enabling precise tissue manipulation and hemostasis during surgery.

These probes are supplied as reusable medical devices and are intended for use in sterile surgical environments. They are not MRI-compatible and must be handled according to standard electrosurgical safety protocols. The models MPJ200, MPJ210, MPS220, MPN230, and BPH240 are authorized under FDA 510(k) clearance (K102275) and are regulated under the General and Plastic Surgery advisory committee. Proper storage and maintenance are required to ensure device performance and patient safety.

Frequently asked questions

What are the Thermedx 37-5 Electrocautery Probes used for?

The Thermedx 37-5 Electrocautery Probes are designed for cutting and coagulation in urological, gynecological, laparoscopic, and general surgical procedures. They deliver controlled electrical energy to tissue for precise manipulation and hemostasis during surgery.

Are these probes reusable or single-use devices?

The Thermedx 37-5 Electrocautery Probes are supplied as reusable medical devices intended for use in sterile surgical environments. Proper storage and maintenance are required to ensure device performance and patient safety.

What models are available in the Thermedx 37-5 Electrocautery Probes series?

The Thermedx 37-5 Electrocautery Probes series includes five models: MPJ200, MPJ210, MPS220, MPN230, and BPH240. Each model is authorized under FDA 510(k) clearance (K102275) and regulated under the General and Plastic Surgery advisory committee.

Are these MRI-compatible?

No, the Thermedx 37-5 Electrocautery Probes are not MRI-compatible. They must be handled according to standard electrosurgical safety protocols to ensure proper function and patient safety during surgical procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Thermedx 37-5 Electrocautery Probes, Models Mpj200, Mpj210, Mps220 ..., fda.innolitics.com, PDF 510(k) Summary MAR 2 5 20H1 - Food and Drug Administration, THERMEDX, LLC FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Thermedx, LLC

Sources (1)

  • FDA 510(k) K102275 24 fields · synced Oct 6, 2026