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FDA 510(k)

Orbit Subretinal Delivery System

K-Number: K182274 · 2018-11-20

ApplicantOrbit Biomedical, Inc.
Decision Date2018-11-20
Product CodeFMF
Advisory CommitteeHO
DecisionUnknown

Device Summary

Orbit Subretinal Delivery System is a medical device manufactured by Orbit Biomedical, Inc.. It received FDA 510(k) clearance on 2018-11-20 under approval number K182274. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

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 2018-11-20. It is manufactured by Orbit Biomedical, Inc.. The 510(k) number is K182274.

When was Orbit Subretinal Delivery System approved by the FDA?

Orbit Subretinal Delivery System received FDA 510(k) clearance on 2018-11-20, under approval number K182274.

What company makes Orbit Subretinal Delivery System?

Orbit Subretinal Delivery System is manufactured by Orbit Biomedical, Inc..

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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