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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K253230
Device Name ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
Applicant
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen,  DE 72072
Applicant Contact Matthias Kollek
Correspondent
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen,  DE 72072
Correspondent Contact Matthias Kollek
Regulation Number878.4350
Classification Product Code
GEH  
Date Received09/29/2025
Decision Date 04/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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