FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
K Number: K002427
·
Decision Jun 22, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
68
Applicant Total
16
Review Days
318
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
- SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026
- K Number
- K002427
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sandhill Scientific, Inc.
- Date Received
- August 8, 2000
- Decision Date
- June 22, 2001
- Product Code
- FFX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFX), ordered by most recent decision date.
mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Solar Compact (G4-1)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EndoflipTM 300 System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EndoflipTM 300
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Transit-Pellets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IntraMarX 3D Radiopaque Marker
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Sandhill Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111013 | ACEM | Dec 19, 2011 | Substantially Equivalent |
| K012232 | INSIGHT, MODEL S980000 | Jun 7, 2002 | Substantially Equivalent |
| K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | Feb 28, 2002 | Substantially Equivalent |
| K990441 | INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 | May 12, 1999 | Substantially Equivalent |
| K984444 | INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 | Jan 11, 1999 | Substantially Equivalent |
| K961056 | BIOVIEW MODEL S960000 | Jun 6, 1996 | Substantially Equivalent |
| K942247 | SMALL BOWEL ANALYSIS SOFTWARE | Apr 9, 1996 | Substantially Equivalent |
| K941801 | ANALGRAPH | Sep 8, 1995 | Substantially Equivalent |
| K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | Sep 28, 1994 | Substantially Equivalent |
| K926218 | EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) | Aug 26, 1994 | Substantially Equivalent |