Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
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
- QRK
- Zip code
- 215253
- Applicant
- SteriLance Medical (Suzhou), Inc.
- Decision date
- 2025-02-26
- Decision code
- SESE
- Country code
- CN
- Device name
- Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
- Advisory committee
- SU
- Contact
- Susan Sun
- K number
- K244031
- Date received
- 2024-12-30
- Review advisory committee
- SU
- Postal code
- 215253
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4850
- Device class
- 2
- Registration number
- 3011121740, 3008191276, 3015058854, 1058602, 3004130086, 3003674698, 3007134734, 3009578786, 3007363438, 3013223546, 3017500903, 1066444, 3006899020, 3011065399, 3044026004, 3003741676, 3024512705, 3018940143, 3006532271, 3045951983, 3006142663, 3025413691, 3009498548, 3038419886, 3012118659, 3038356900, 9613304, 3016450032, 3030186688, 3004468256, 3005644014, 2416465, 3009171251, 3008780388, 3011617315, 3004146366, 1832816, 1058955, 3024273968, 3007382160 +42 more
- FEI number
- 3008191276, 3015058854, 3004130086, 3003674698, 3007134734, 3009578786, 3013223546, 3017500903, 1000600761, 3006899020, 3011065399, 3044026004, 3002924544, 3024512705, 3003741676, 3018940143, 3006532271, 3045951983, 3006142663, 3025413691, 3009498548, 3038419886, 3012118659, 3038356900, 3016450032, 1000219614, 3030186688, 3004468256, 3005644014, 2416465, 3008780388, 3011617315, 1000525253, 3004146366, 1832816, 3003405786, 3008801456, 3024273968, 3007382160, 3004637226 +42 more