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 a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2024-10-17 under approval 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. It is manufactured by Astura Medical. The 510(k) number is K240160.
When was EGPS Navigated Instruments approved by the FDA?
EGPS Navigated Instruments received FDA 510(k) clearance on 2024-10-17, under approval number K240160.
What company makes EGPS Navigated Instruments?
EGPS Navigated Instruments is manufactured by Astura Medical.
What is the FDA product code for EGPS Navigated Instruments?
The FDA product code for EGPS Navigated Instruments is 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.