Identifiers
- 510(k) Number
- K222224 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)
The SurgiLance Safety Lancet is a single-use, disposable device classified as a safety lancet (product code FMK) designed for capillary blood collection. It is engineered to minimize patient discomfort and reduce the risk of needlestick injuries by incorporating a retractable or blunt-tip mechanism. This device is intended for healthcare professionals performing routine blood sampling procedures, such as fingerstick tests. Its design adheres to standards for safety and ease of use in clinical settings.
The SurgiLance Safety Lancet is supplied as a sterile, single-use device, ensuring patient safety and infection control. It is intended for use in outpatient clinics, hospitals, and home healthcare settings where capillary blood sampling is required. The device is FDA-cleared under the 510(k) pathway as substantially equivalent to predicate devices, with a clearance date of September 22, 2022. No additional regulatory markings or MRI safety classifications are specified in the available data.
Frequently asked questions
What is the SurgiLance Safety Lancet designed for?
The SurgiLance Safety Lancet is specifically engineered for healthcare professionals to perform capillary blood collection, such as fingerstick tests. Its retractable or blunt-tip mechanism minimizes patient discomfort and lowers the risk of needlestick injuries, making it ideal for routine blood sampling in outpatient clinics, hospitals, and home healthcare environments.
How is the SurgiLance Safety Lancet supplied and what does this mean for infection control?
The SurgiLance Safety Lancet is supplied as a sterile, single-use device. This ensures that each lancet is uncontaminated before use, reducing the risk of cross-infection between patients. Single-use devices are also designed for one-time use only, which helps maintain hygiene and compliance with infection control protocols in clinical settings.
Is the SurgiLance Safety Lancet reusable or intended for single-use?
The SurgiLance Safety Lancet is explicitly designed for single-use only. This design choice aligns with best practices for infection control and patient safety, as reusable devices carry risks of contamination and degradation over time. The manufacturer emphasizes its disposable nature to ensure reliability and sterility with every use.
What regulatory pathway does the SurgiLance Safety Lancet follow?
The SurgiLance Safety Lancet has been cleared by the FDA under the 510(k) pathway, specifically as substantially equivalent to predicate devices. This clearance was granted on September 22, 2022, confirming its compliance with U.S. regulatory standards for safety and performance in capillary blood collection procedures.
Where can the SurgiLance Safety Lancet be used, and what settings is it suitable for?
The SurgiLance Safety Lancet is intended for use in a variety of clinical settings, including outpatient clinics, hospitals, and home healthcare environments. Its design prioritizes safety and ease of use, making it particularly well-suited for environments where capillary blood sampling is a frequent requirement, such as diabetes management, routine lab tests, or point-of-care diagnostics.
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: MediPurpose - Safety Medical Devices, SurgiLance & babyLance, Surgilance - MediPurpose, Safety Lancets, SurgiLance - Penn Care, Inc., PDF MediPurpose Pte. Ltd. CONFIDENTIAL K101 145 SurgiLance®
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222224 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medipurpose Pte. Ltd.
- FDA Applicant
- Medipurpose Pte. , Ltd.
Sources (1)
- FDA 510(k) K222224 24 fields · synced Oct 1, 2026