FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPERJET DISPOSABLE BLOOD LANCET
K Number: K833812
·
Decision Dec 12, 1983
Classifications
1
FEI Numbers
157
Registration Numbers
157
Same Product Code
109
Applicant Total
1
Review Days
40
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SUPERJET DISPOSABLE BLOOD LANCET
- K Number
- K833812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Medrobe Laboratories
- Date Received
- November 2, 1983
- Decision Date
- December 12, 1983
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMK), ordered by most recent decision date.
Verifine Safety Lancets
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safety lancet (XXXVII)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safety Heel Lancet
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
safety lancet
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Heel Incision Safety Lancet (SteriHeel 2)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery