Heel Incision Safety Lancet (SteriHeel 2)
SteriLance Medical (Suzhou), Inc. · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Suzhou
- Advisory committee description
- General, Plastic Surgery
- Address 1
- #168 Putuoshan Rd., New District
- Statement or summary
- Summary
- Product code
- FMK
- Zip code
- 215153
- Applicant
- SteriLance Medical (Suzhou), Inc.
- Decision date
- 2025-02-26
- Decision code
- SESE
- Country code
- CN
- Device name
- Heel Incision Safety Lancet (SteriHeel 2)
- Advisory committee
- SU
- Contact
- Susan Sun
- K number
- K244036
- Date received
- 2024-12-30
- Review advisory committee
- SU
- Postal code
- 215153
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4850
- Device class
- 2
- Registration number
- 2648045, 3030446844, 3003965134, 3015347724, 3008191276, 3015058854, 3002721930, 1058602, 3026940910, 3012026312, 3007134734, 3009578786, 3003902721, 3013019728, 3008337059, 3007363438, 1722458, 3002680783, 3011526299, 2531491, 3042871620, 1066444, 3006899020, 3043226252, 1722684, 3015140199, 3011137372, 3012172036, 3044026004, 3030171742, 3010834934, 3008936260, 3042854290, 3003917514, 3017923561, 3011088743, 3012448339, 3031789039, 3010131137, 8020040 +124 more
- FEI number
- 2648045, 3030446844, 3003965134, 3015347724, 3008191276, 3015058854, 3000974732, 3026940910, 3012026312, 3007134734, 3009578786, 3003902721, 3013019728, 3008337059, 1000600761, 3002680783, 3011526299, 3042871620, 3006899020, 3043226252, 3015140199, 3002808075, 3012172036, 3002924544, 2250033, 2649711, 3044026004, 3030171742, 3010834934, 3008936260, 3042854290, 3003917514, 3017923561, 3011088743, 3012448339, 3031789039, 3001239292, 3010131137, 1417592, 3006142663 +124 more