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FDA 510(k)

OLYMPIC Navigated Instruments

K-Number: K172166 · 2018-04-27

ApplicantAstura Medical
Decision Date2018-04-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OLYMPIC Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2018-04-27 under 510(k) number K172166. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPIC Navigated Instruments?

OLYMPIC Navigated Instruments is a medical device that received FDA 510(k) clearance on 2018-04-27. The listed applicant is Astura Medical. The 510(k) number is K172166.

When did OLYMPIC Navigated Instruments receive FDA 510(k) clearance?

OLYMPIC Navigated Instruments received FDA 510(k) clearance on 2018-04-27, under 510(k) number K172166.

Who is the listed applicant for OLYMPIC Navigated Instruments?

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

What is the FDA product code for OLYMPIC Navigated Instruments?

The FDA product code for OLYMPIC Navigated Instruments is OLO.

Other records listing Astura Medical as applicant

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Related Devices (Code: OLO)

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

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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