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FDA 510(k)

EGPS Navigated Instruments

K-Number: K240160 · 2024-10-17

ApplicantAstura Medical
Decision Date2024-10-17
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EGPS 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 2024-10-17 under 510(k) number K240160. 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 EGPS Navigated Instruments?

EGPS Navigated Instruments is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Astura Medical. The 510(k) number is K240160.

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

EGPS Navigated Instruments received FDA 510(k) clearance on 2024-10-17, under 510(k) number K240160.

Who is the listed applicant for EGPS 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 EGPS Navigated Instruments?

The FDA product code for EGPS Navigated Instruments is OLO.

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Related Devices (Code: OLO)

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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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