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FDA 510(k)

Orbit Subretinal Delivery System

K-Number: K200325 · 2020-07-14

ApplicantOrbit Biomedical
Decision Date2020-07-14
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Orbit Subretinal Delivery System is a medical device manufactured by Orbit Biomedical. It received FDA 510(k) clearance on 2020-07-14 under approval number K200325. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orbit Subretinal Delivery System?

Orbit Subretinal Delivery System is a medical device that received FDA 510(k) clearance on 2020-07-14. It is manufactured by Orbit Biomedical. The 510(k) number is K200325.

When was Orbit Subretinal Delivery System approved by the FDA?

Orbit Subretinal Delivery System received FDA 510(k) clearance on 2020-07-14, under approval number K200325.

What company makes Orbit Subretinal Delivery System?

Orbit Subretinal Delivery System is manufactured by Orbit Biomedical.

What is the FDA product code for Orbit Subretinal Delivery System?

The FDA product code for Orbit Subretinal Delivery System is FMF.

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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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