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FDA 510(k)

Clearlink System Solution Set

K-Number: K180739 · 2019-05-28

ApplicantBaxter Healthcare Corporation
Decision Date2019-05-28
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Clearlink System Solution Set is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2019-05-28 under approval number K180739. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clearlink System Solution Set?

Clearlink System Solution Set is a medical device that received FDA 510(k) clearance on 2019-05-28. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K180739.

When was Clearlink System Solution Set approved by the FDA?

Clearlink System Solution Set received FDA 510(k) clearance on 2019-05-28, under approval number K180739.

What company makes Clearlink System Solution Set?

Clearlink System Solution Set is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for Clearlink System Solution Set?

The FDA product code for Clearlink System Solution Set is FPA.

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Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

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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.

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