Identifiers
- 510(k) Number
- K203264 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MicroDose Injector is an injection kit designed for ophthalmic procedures. It features a silicone-free syringe to eliminate the risk of silicone droplets being introduced into the eye and a unique stopper designed to reduce dead-space to approximately 1.0 microliters.
The device has a 1 mL syringe volume for precise dosing and includes a removable plunger for flexibility in usage. It is sterilized for safety and supplied as single-use to prevent infection. The MicroDose Injector received FDA 510(k) clearance (K203264) and is regulated under product code FMF.
Frequently asked questions
What is the MicroDose Injector used for?
The MicroDose Injector is designed for ophthalmic procedures, enabling precise delivery of medication into the eye with minimal risk of contamination due to its silicone-free syringe and reduced dead-space stopper.
Is the MicroDose Injector sterile and single-use?
Yes, the MicroDose Injector is sterilized for safety and supplied as a single-use device to prevent infection and ensure sterility during ophthalmic injections.
What are the key features of the MicroDose Injector syringe?
The syringe has a 1 mL volume for precise dosing, is silicone-free to avoid introducing silicone droplets into the eye, and includes a removable plunger for flexible use during procedures.
How does the MicroDose Injector reduce dead-space?
The device features a unique stopper design that reduces dead-space to approximately 1.0 microliters, minimizing medication waste and improving dosing accuracy in small-volume ophthalmic injections.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MicroDose Injection Kit - MedOne Surgical, Medone Surgical MEDONE MICRODOSE INJECTION 5/B, Medone Surgical MICRODOSE INJECTION KIT 5/BX, MicroDose Injector by MedOne Surgical, Inc. | FDA 510(k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203264 | Class II | Active |
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Manufacturer
- Manufacturer
- MedOne Surgical, Inc.
Sources (1)
- FDA 510(k) K203264 24 fields · synced Oct 1, 2026