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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cystoscope and accessories, flexible/rigid
510(k) Number K212476
Device Name KARL STORZ Flexible HD Cysto-Urethroscope System
Applicant
KARL STORZ Endoscopy America, Inc.
2151 E. Grand Ave
El Segundo,  CA  90245
Applicant Contact Winkie Wong
Correspondent
KARL STORZ Endoscopy America, Inc.
2151 E. Grand Ave
El Segundo,  CA  90245
Correspondent Contact Thomas Ostrowski
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Code
FBO  
Date Received08/06/2021
Decision Date 09/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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