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Thermoflex System

by Argomed, Inc. 2 variants

510(k) K000508

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000508 Date18 Apr 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Thermoflex System is an electrosurgical unit for endoscopic use, designed for procedures in gastroenterology and urology. It consists of an extracorporeal heat source and a proprietary closed-loop catheter system that delivers heated water for treatment.

The device is supplied as a system with various model numbers and registration numbers. It is a Class II device cleared by the FDA through a traditional 510(k) process on April 18, 2000, with K000508. The system is intended for use in clinical settings under appropriate regulatory authorizations.

Other devices from Argomed, Inc.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Thermoflex System used for?

    The Thermoflex System is an electrosurgical unit designed for endoscopic procedures in gastroenterology and urology. It consists of an extracorporeal heat source and a proprietary closed-loop catheter system that delivers heated water for treatment.

  • How is the Thermoflex System supplied?

    The device is supplied as a complete system with various model numbers and registration numbers. It includes the main electrosurgical unit and the proprietary catheter system designed for specific medical procedures.

  • What is the regulatory status of the Thermoflex System?

    The Thermoflex System is a Class II device cleared by the FDA through a traditional 510(k) process on April 18, 2000, with K000508. It is intended for use in clinical settings under appropriate regulatory authorizations.

  • What specialties typically use the Thermoflex System?

    The Thermoflex System is designed for use in gastroenterology and urology procedures. It was reviewed by the Gastroenterology, Urology (GU) advisory committee during the FDA clearance process.