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MicroMed PD-8K Insulation Defect Detector

by Mcgan Technology, LLC

510(k) K101606

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101606 Date1 Oct 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HFG
Device Class
Class II
Regulation
21 CFR Part 884.4160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The MicroMed PD-8K Insulation Defect Detector is a non-destructive, non-patient contact, high voltage insulation tester designed to test the insulation integrity of electrosurgical instruments. It is a battery-operated unit that detects defects such as pinholes, cracks, or other insulation failures in electrosurgical tools.

The device is supplied as a kit or system for use in clinical settings where electrosurgical instruments are prepared or maintained. It is intended for non-patient contact testing and is regulated under FDA 510(k) clearance K101606, with product code HFG and classified as a Class II device under regulation number 884.4160.

Questions

AI-generated answers, 1 Oct 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 MicroMed PD-8K Insulation Defect Detector used for?

    It is used to test the insulation integrity of electrosurgical instruments by detecting defects such as pinholes, cracks, or other insulation failures without contacting the patient, ensuring instrument safety before clinical use.

  • How is the MicroMed PD-8K supplied and powered?

    The device is supplied as a kit or system for clinical use and operates on battery power, allowing portable, non-destructive testing of electrosurgical tools in settings where instruments are prepared or maintained.

  • Is the MicroMed PD-8K intended for patient contact during testing?

    No, the device is designed for non-patient contact testing only; it evaluates insulation integrity of electrosurgical instruments externally, without any direct contact with the patient during operation.