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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 K260271
Device Name Strauss Surgical cystoscope, hysteroscope and accessories Instruments
Applicant
American Medical Endoscopy, Inc.
3020 NW 82nd Ave.
Doral,  FL  33122
Applicant Contact Matthew Schwimmer
Correspondent
Shaily Shah
345 Lincoln Hill Rd.
Shrewsbury,  VT  05788
Correspondent Contact Shaily Shah
Regulation Number876.1500
Classification Product Code
FAJ  
Subsequent Product Code
HIH  
Date Received01/28/2026
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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