FDA 510(k)

SOLOPASS System

K-Number: K203251 · 2021-08-27

Decision Date2021-08-27

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SOLOPASS System is the device name listed in this FDA 510(k) record. The listed applicant is Intravent Medical Partners, LP. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K203251. 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 System?

SOLOPASS System is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Intravent Medical Partners, LP. The 510(k) number is K203251.

When did SOLOPASS System receive FDA 510(k) clearance?

SOLOPASS System received FDA 510(k) clearance on 2021-08-27, under 510(k) number K203251.

Who is the listed applicant for SOLOPASS System?

The FDA 510(k) record lists Intravent Medical Partners, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLOPASS System?

The FDA product code for SOLOPASS System is HAW.

Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB K253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners K250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

Official Source

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