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Myocard Biopsy Forcep

by Fehling Medizintechnik GmbH 510(k)

Active United States

510(k) K881412

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881412 Date8 Sep 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DWZ
Device Class
Class II
Regulation
21 CFR Part 870.4075
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

This device is a myocardial biopsy forcep designed for taking tissue samples for histologic examination, especially endomyocardial biopsy. It is a manually operated instrument used to obtain cardiac tissue specimens for diagnostic evaluation.

The device is supplied non-sterile and intended for single use by qualified medical staff. It is regulated under FDA 510(k) clearance K881412, with product code DWZ and regulation number 870.4075, and is classified as a Class II medical device for cardiovascular applications.

Questions

AI-generated answers, 25 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 MYOCARD BIOPSY FORCEP used for?

    The MYOCARD BIOPSY FORCEP is designed for taking tissue samples for histologic examination, specifically endomyocardial biopsy, to obtain cardiac tissue specimens for diagnostic evaluation by qualified medical staff.

  • How is the MYOCARD BIOPSY FORCEP supplied and is it sterile?

    The device is supplied non-sterile and intended for single use only, meaning it should not be reprocessed or reused after a procedure to ensure patient safety and prevent cross-contamination.

  • What regulatory pathway was used for the MYOCARD BIOPSY FORCEP?

    The MYOCARD BIOPSY FORCEP received FDA 510(k) clearance under number K881412, is classified as a Class II medical device, and is regulated under product code DWZ and regulation number 870.4075 for cardiovascular applications.