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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 the device name listed in this FDA 510(k) record. The listed applicant is Clearpath Surgical, Inc.. It received FDA 510(k) clearance on 2017-02-07 under 510(k) 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. The listed applicant is Clearpath Surgical, Inc.. The 510(k) number is K163214.

When did Unicare System, Unicare Manipulator receive FDA 510(k) clearance?

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

Who is the listed applicant for Unicare System, Unicare Manipulator?

The FDA 510(k) record lists Clearpath Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: LKF)

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.

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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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