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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K261706
Device Name Endomat Select (UP220)
Applicant
KARL STORZ SE & CO. KG
Dr.-Karl-Storz-Strabe 34
Tuttlingen,  DE 78532
Applicant Contact Emily Rhiel
Correspondent
KARL STORZ SE & CO. KG
Dr.-Karl-Storz-Strabe 34
Tuttlingen,  DE 78532
Correspondent Contact Emily Rhiel
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Codes
BTA   EOB   HRX   LJH   OCX  
Date Received05/22/2026
Decision Date 07/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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