FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL OSP, SANDHILL AMS
K Number: K904231
·
Decision Jan 2, 1991
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
121
Applicant Total
16
Review Days
127
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
- MODEL OSP, SANDHILL AMS
- K Number
- K904231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Sandhill Scientific, Inc.
- Date Received
- August 28, 1990
- Decision Date
- January 2, 1991
- Product Code
- FAD
- 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 |
|---|---|---|---|
| FAD | Stent, Ureteral | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAD), ordered by most recent decision date.
Disposable Ureteral Stents
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endura Ureteral Stent and Stent Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ureteral Stents (AF-D series)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Disposable ureteral stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
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 |
| K002427 | SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 | Jun 22, 2001 | 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 |