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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K251317
Device Name SOLOPASS 2.0 System
Applicant
Intravent Medical Partners
1730 Walton Rd.
Suite 110
Blue Bell,  PA  19422
Applicant Contact Adam Barner
Correspondent
ProPharma MedTech
107 W. Hargett St.
Raleigh,  NC  27601
Correspondent Contact Connie Qiu
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
IYN  
Date Received04/29/2025
Decision Date 09/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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