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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K242772
Device Name AirSurgN Insufflator (10030/AirSurgN)
Applicant
Smartsurgn, Inc.
1038 Leigh Ave. Suite 101b
San Jose,  CA  95126
Applicant Contact Jocelyn Long
Correspondent
Smartsurgn, Inc.
1038 Leigh Ave. Suite 101b
San Jose,  CA  95126
Correspondent Contact Jocelyn Long
Regulation Number884.1730
Classification Product Code
HIF  
Date Received09/13/2024
Decision Date 04/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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