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FDA 510(k)

Unicare System, Unicare Manipulator

K-Number: K163214 · 2017-02-07

ApplicantClearpath Surgical, Inc.
Decision Date2017-02-07
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Unicare System, Unicare Manipulator is a medical device manufactured by Clearpath Surgical, Inc.. It received FDA 510(k) clearance on 2017-02-07 under approval number K163214. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unicare System, Unicare Manipulator?

Unicare System, Unicare Manipulator is a medical device that received FDA 510(k) clearance on 2017-02-07. It is manufactured by Clearpath Surgical, Inc.. The 510(k) number is K163214.

When was Unicare System, Unicare Manipulator approved by the FDA?

Unicare System, Unicare Manipulator received FDA 510(k) clearance on 2017-02-07, under approval number K163214.

What company makes Unicare System, Unicare Manipulator?

Unicare System, Unicare Manipulator is manufactured by Clearpath Surgical, Inc..

What is the FDA product code for Unicare System, Unicare Manipulator?

The FDA product code for Unicare System, Unicare Manipulator is LKF.

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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.

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