Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOLOPASS 2.0 System

K-Number: K251317 · 2025-09-05

ApplicantIntravent Medical Partners
Decision Date2025-09-05
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOLOPASS 2.0 System is a medical device manufactured by Intravent Medical Partners. It received FDA 510(k) clearance on 2025-09-05 under approval number K251317. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLOPASS 2.0 System?

SOLOPASS 2.0 System is a medical device that received FDA 510(k) clearance on 2025-09-05. It is manufactured by Intravent Medical Partners. The 510(k) number is K251317.

When was SOLOPASS 2.0 System approved by the FDA?

SOLOPASS 2.0 System received FDA 510(k) clearance on 2025-09-05, under approval number K251317.

What company makes SOLOPASS 2.0 System?

SOLOPASS 2.0 System is manufactured by Intravent Medical Partners.

What is the FDA product code for SOLOPASS 2.0 System?

The FDA product code for SOLOPASS 2.0 System is HAW.

Related Clinical Trials

NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING

Related Devices (Code: HAW)

K162604Cranial Reducing TubesMedtronic Navigation, Inc. K160811CRW STEREOTACTIC SYSTEMIntegra LifeSciences Corporation K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. K152764EXACTECH GPSBlue Ortho K160523BrightMatter Guide with BrightMatter PointerSynaptive Medical, Inc. K151156Fiagon Navigation SystemFiagon GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑