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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K213597
Device Name MultiCut Solo
Applicant
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena,  DE 07747
Applicant Contact Tom Gruender
Correspondent
Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
Jena,  DE 07747
Correspondent Contact Tom Gruender
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/12/2021
Decision Date 01/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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