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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 the device name listed in this FDA 510(k) record. The listed applicant is Orbit Biomedical, Inc.. It received FDA 510(k) clearance on 2018-11-20 under 510(k) 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. The listed applicant is Orbit Biomedical, Inc.. The 510(k) number is K182274.

When did Orbit Subretinal Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for Orbit Subretinal Delivery System?

The FDA 510(k) record lists Orbit Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Orbit Biomedical, Inc. as applicant

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.

K200325Orbit Subretinal Delivery System

Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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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