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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 K263075
Device Name Strauss Surgical Cystoscope/Hysteroscope and Accessories Instruments
Applicant
Strauss Surgical USA
3020 NW 82nd Ave.
Doral,  FL  33122
Applicant Contact Antonio Nava
Correspondent
Medical Device Academy
345 Lincoln Hill Rd.
Shrewsbury,  VT  05788
Correspondent Contact Rob Packard
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Code
HIH  
Date Received09/02/2026
Decision Date 10/30/2026
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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