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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resectoscope
510(k) Number K221893
Device Name KARL STORZ Bipolar Resectoscopes with HF Cable
Applicant
KARL STORZ Endoscopy America, Inc
2151 E. Grand Avenue
El Segundo,  CA  90245
Applicant Contact Leigh Spotten
Correspondent
KARL STORZ Endoscopy America, Inc
2151 E. Grand Avenue
El Segundo,  CA  90245
Correspondent Contact Mario Trujillo
Regulation Number876.1500
Classification Product Code
FJL  
Subsequent Product Codes
FAS   FDC   GEI   HIH  
Date Received06/29/2022
Decision Date 03/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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