Disposable Blood Lancet
FDA 510(k) clearance K221507 · decided 2022-08-31
Clearance details
- K-number
- K221507
- Device name
- Disposable Blood Lancet
- Applicant
- SteriLance Medical (Suzhou), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-23
- Decision date
- 2022-08-31
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- QRK
- Device class
- 2
- Regulation number
- 878.4850
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Suzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.