MiniLoad Syringe
FDA 510(k)Class II (US FDA 510(k))
by Ocuject, LLC
Identifiers
- 510(k) Number
- K212544 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 MiniLoad Syringe is a piston syringe classified under product code FMF and regulation number 21 CFR 880.5860. It is a general hospital and personal use therapeutic device.
The device received FDA 510(k) clearance (K212544) on October 13, 2021, and is manufactured by Ocuject, LLC in Newport Beach, California. It is a Class II device with special controls.
Frequently asked questions
What is the MiniLoad Syringe used for?
The MiniLoad Syringe is a piston syringe intended for general hospital and personal use therapeutic applications, as indicated by its classification under product code FMF and regulation 21 CFR 880.5860.
How is the MiniLoad Syringe supplied and is it sterile?
The device data does not specify whether the MiniLoad Syringe is supplied sterile or non-sterile, or details about its packaging or supply configuration; therefore, sterility and supply format cannot be confirmed from the provided information.
Is the MiniLoad Syringe designed for single-use or reuse?
The provided device data does not include information about whether the MiniLoad Syringe is intended for single-use or reuse, so this detail cannot be determined from the authorization or specifications listed.
What sizes or models are available for the MiniLoad Syringe?
No specific sizes, models, or reference numbers beyond the device name 'MiniLoad Syringe' are provided in the data, so variant details such as volume capacities or model designations are not available.
What regulatory pathway was used for the MiniLoad Syringe?
The MiniLoad Syringe received FDA 510(k) clearance under submission K212544, indicating it was cleared as substantially equivalent to a legally marketed predicate device.
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: MiniLoad Syringe (K212544) — FDA 510 (k) | Innolitics, K202432 - MiniLoad Syringe | FDA 510 (k) | Ocuject, LLC, PDF Rebecca Pine Official Correspondent Trade/Device Name: MiniLoad Syringe ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212544 | Class II | Active |
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Manufacturer
- Manufacturer
- Ocuject, LLC
Sources (1)
- FDA 510(k) K212544 24 fields · synced Sep 21, 2026