FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNISTIK
K Number: K920562
·
Decision Mar 27, 1992
Classifications
1
FEI Numbers
157
Registration Numbers
157
Same Product Code
109
Applicant Total
20
Review Days
50
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
- UNISTIK
- K Number
- K920562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4850
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ulster Scientific, Inc.
- Date Received
- February 6, 1992
- Decision Date
- March 27, 1992
- 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
Other Clearances by Ulster Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942620 | FEATHER-TOUCH SINGLE-STICK DEVICE | Jun 22, 1994 | Substantially Equivalent |
| K902592 | EPC ELECTRONIC PIPETTING SYSTEM | Jul 19, 1990 | Substantially Equivalent |
| K895890 | AUTOPEN | Feb 16, 1990 | Substantially Equivalent |
| K894474 | THE AUTOLET LITE | Aug 18, 1989 | Substantially Equivalent |
| K885340 | AIR DISPLACEMENT PIPETTE | Feb 14, 1989 | Substantially Equivalent |
| K875354 | UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM | Feb 17, 1988 | Substantially Equivalent |
| K871571 | NEUROTIPS(TM) | Jun 18, 1987 | Substantially Equivalent |
| K871076 | WINPETTE | Mar 23, 1987 | Substantially Equivalent |
| K870078 | ACCUPEN(R) | Mar 17, 1987 | Substantially Equivalent |
| K864761 | USI AUTOJECT INSULIN SYRINGE | Dec 16, 1986 | Substantially Equivalent |