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Wundcath Conduction Catheter

by Micor, Inc.

510(k) K003966

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 NumberK003966 Date17 Jul 2001ClearedStatusActive

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  • Withdrawn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
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Wundcath Conduction Catheter is a medical device used for conduction purposes. It is classified as a class 2 device under the general hospital specialty.

This device is authorized for use under FDA 510(k) clearance K003966. It is manufactured by Micor, Inc. and is subject to the regulations defined under 880.5725.

Other devices from Micor, Inc.

See all devices from Micor, Inc. →

Questions

AI-generated answers, 6 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 primary purpose of the Wundcath Conduction Catheter?

    The Wundcath Conduction Catheter is a medical device specifically designed for conduction purposes within a clinical setting.

  • How is the Wundcath Conduction Catheter classified?

    This device is classified as a class 2 medical device under the general hospital specialty, as defined by regulation 880.5725.

  • What is the regulatory status of this device?

    The Wundcath Conduction Catheter is authorized for use under FDA 510(k) clearance number K003966, which was granted on July 17, 2001.