FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUEL BLOOD LANCET
K Number: K861151
·
Decision Apr 15, 1986
Classifications
1
FEI Numbers
157
Registration Numbers
157
Same Product Code
109
Applicant Total
18
Review Days
20
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Basic Information
- Device Name
- SUEL BLOOD LANCET
- K Number
- K861151
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Exel Intl.
- Date Received
- March 26, 1986
- Decision Date
- April 15, 1986
- Product Code
- FMK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Exel Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K992290 | EXEL INJECTION PLUG WITH CAP | Feb 23, 2000 | Substantially Equivalent |
| K963658 | EXEL AVF SINGLE NEEDLE | May 5, 1998 | Substantially Equivalent |
| K963659 | EXEL I.V. ADMINISTRATION SET | Dec 16, 1997 | Substantially Equivalent |
| K926119 | EXEL HUBER INFUSION SET ROTATING WING | Aug 11, 1993 | Substantially Equivalent |
| K904685 | EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) | Nov 21, 1990 | Substantially Equivalent |
| K903945 | EXEL A-V FISTULA SET | Nov 20, 1990 | Substantially Equivalent |
| K895770 | EXEL HUBER INFUSION SET | Jul 19, 1990 | Substantially Equivalent |
| K895768 | EXEL SAFELET CATHETER | Feb 16, 1990 | Substantially Equivalent |
| K895772 | EXEL INDWELLING CATHETER | Feb 16, 1990 | Substantially Equivalent |
| K895771 | EXEL SPINAL NEEDLES | Feb 16, 1990 | Substantially Equivalent |