Identifiers
- 510(k) Number
- K222303 FDA 510(k)
- FDA Product Code
- FMK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4850 FDA 510(k)
- Regulation Number
- 878.4850 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Unistik Pro is a single-use safety lancet designed for capillary blood sampling. It features a syringe-like grip and a push-button design for intuitive use.
The device is supplied sterile and is intended for use by healthcare professionals. It is not reusable and has FDA 510(k) authorization.
Frequently asked questions
What is the Unistik Pro used for?
The Unistik Pro is a single-use safety lancet designed for capillary blood sampling, such as for glucose monitoring or diagnostic testing.
Is the Unistik Pro reusable?
No, the Unistik Pro is a single-use device and is not intended for reuse to ensure safety and prevent cross-contamination.
How is the Unistik Pro supplied?
The device is supplied sterile and is intended for use by healthcare professionals.
What are the key features of the Unistik Pro?
It features a syringe-like grip and a push-button design for intuitive and easy use.
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: Unistik® Pro Plus | Owen Mumford, Unistik Pro | Owen Mumford, K222303 FDA 510(k) - Unistik Pro | Owen Mumford, Ltd., Unistik® 3 | Owen Mumford, Owen Mumford™ Unistik™ Pro Single Use Safety Lancet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222303 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Owen Mumford Ltd
- FDA Applicant
- Owen Mumford, Ltd.
Sources (1)
- FDA 510(k) K222303 24 fields · synced Sep 23, 2026