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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K223520
Device Name UNIDRIVE SIII System
Applicant
Karl Storz-Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo,  CA  90245
Applicant Contact Alita McElroy
Correspondent
Karl Storz-Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Alita McElroy
Regulation Number884.1690
Classification Product Code
HIH  
Date Received11/23/2022
Decision Date 04/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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