FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEUROTIPS(TM)
K Number: K871571
·
Decision Jun 18, 1987
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
6
Applicant Total
20
Review Days
57
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
- NEUROTIPS(TM)
- K Number
- K871571
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.1500
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Ulster Scientific, Inc.
- Date Received
- April 22, 1987
- Decision Date
- June 18, 1987
- Product Code
- GXB
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXB | Esthesiometer | FDA class 1 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXB), ordered by most recent decision date.
Medical Monofilament Sensory Screening Toool
FDA 510(k)
FDA Class 1
·Neurology
NU-PREP GEL
FDA 510(k)
FDA Class 1
·Neurology
ALGESIOMETER
FDA 510(k)
FDA Class 1
·Neurology
AESTHESIOMETER
FDA 510(k)
FDA Class 1
·Neurology
TEMP-TESTER
FDA 510(k)
FDA Class 1
·Neurology
AESTHESIOMETER
FDA 510(k)
FDA Class 1
·Neurology
Other Clearances by Ulster Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942620 | FEATHER-TOUCH SINGLE-STICK DEVICE | Jun 22, 1994 | Substantially Equivalent |
| K920562 | UNISTIK | Mar 27, 1992 | 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 |
| 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 |