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510(k) Data Aggregation
K Number
K200325Device Name
Orbit Subretinal Delivery System
Manufacturer
Orbit Biomedical
Date Cleared
2020-07-14
(155 days)
Product Code
FMF, HMX
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Orbit Biomedical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.
Device Description
The Orbit Subretinal Delivery System (SDS) is comprised of 3 primary component sets including the Subretinal Injection Device Set, the Tubing Set, and the Dosing Set. Each Orbit SDS Set contains sterile single-use only components. The Subretinal Injection Device set includes the magnetic pad, ophthalmic marker, and subretinal injection device (SID). The Tubing Set includes the components for priming the BSS line and pneumatic BSS control via a vitreoretinal surgical console. The Dosing Set includes the syringe for delivery of a precise dose of Balanced Salt Solution (BSS) or BSS PLUS® infusate.
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K Number
K182274Device Name
Orbit Subretinal Delivery System
Manufacturer
Orbit Biomedical, Inc.
Date Cleared
2018-11-20
(90 days)
Product Code
FMF, HMX
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Orbit Biomedical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.
Device Description
The Orbit Subretinal Delivery System is designed for microinjection into the subretinal space. The Orbit Subretinal Delivery System is comprised of 2 kits: the Subretinal Access Kit and the Third Arm Kit. All Subretinal Access Kit components are supplied sterile and intended for single-use only and cannot be reused or resterilized. The Subretinal Access Kit contains the following device components: Subretinal Injection Cannula, Ophthalmic Marker, Syringes, and Tubing Set. The assembled Third Arm Kit functions as a "third arm" to stabilize the subretinal injection cannula and free the surgeon's hands during the procedure. The Third Arm Kit (supplied nonsterile) is reusable and must be cleaned and sterilized prior to each use. Together, the Subretinal Access Kit and the Third Arm Kit are to deliver the infusate (e.g., BSS. BSS® PLUS) to the subretinal space as described in the Instructions for Use.
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