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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K252722
Device Name Biopsy Forceps
Applicant
Fehling Instruments GmbH
Hanauer Landstr. 7a
Karlstein,  DE 63791
Applicant Contact Imad Ziate
Correspondent
Fehling Instruments GmbH
Hanauer Landstr. 7a
Karlstein,  DE 63791
Correspondent Contact Imad Ziate
Regulation Number870.4075
Classification Product Code
DWZ  
Date Received08/28/2025
Decision Date 09/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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