FDA 510(k)

Bolt Navigation System

K-Number: K213768 · 2022-12-01

ApplicantCircinus Medical Technology, LLC

Decision Date2022-12-01

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Bolt Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Circinus Medical Technology, LLC. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K213768. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bolt Navigation System?

Bolt Navigation System is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Circinus Medical Technology, LLC. The 510(k) number is K213768.

When did Bolt Navigation System receive FDA 510(k) clearance?

Bolt Navigation System received FDA 510(k) clearance on 2022-12-01, under 510(k) number K213768.

Who is the listed applicant for Bolt Navigation System?

The FDA 510(k) record lists Circinus Medical Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bolt Navigation System?

The FDA product code for Bolt Navigation System is OWB.

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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.