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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Flexible
510(k) Number K212860
Device Name SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
Applicant
Steris Corporation
5976 Heisley Road
Mentor,  OH  44060
Applicant Contact Carroll Martin
Correspondent
Steris Corporation
5976 Heisley Road
Mentor,  OH  44060
Correspondent Contact Carroll Martin
Regulation Number876.4300
Classification Product Code
FDI  
Date Received09/08/2021
Decision Date 10/07/2021
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
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