Lancing System, Sterile Lancet for Single Use, Lancing Device
FDA 510(k) clearance K222472 · decided 2022-11-30
Clearance details
- K-number
- K222472
- Device name
- Lancing System, Sterile Lancet for Single Use, Lancing Device
- Applicant
- Shandong Lianfa Medical Plastic Products Co. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-08-16
- Decision date
- 2022-11-30
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- QRL
- Device class
- 2
- Regulation number
- 878.4850
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Jinan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06 recall (Z-0226-2026) | Home Health US, Incorporated | 2025-10-21 |