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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K251273
Device Name Asurys Fluid Management System
Applicant
Boston Scientific Corporation
300 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Spencer Duncan
Correspondent
Boston Scientific Corporation
300 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Spencer Duncan
Regulation Number884.1700
Classification Product Code
HIG  
Date Received04/24/2025
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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