FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOWMATE HAND PUMP
K Number: K915459
·
Decision Feb 15, 1994
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
7
Review Days
804
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Basic Information
- Device Name
- FLOWMATE HAND PUMP
- K Number
- K915459
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Psi Medical Products, Inc.
- Date Received
- December 4, 1991
- Decision Date
- February 15, 1994
- Product Code
- KOD
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Psi Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931779 | EHL PULSE GENERATOR | Feb 15, 1994 | Substantially Equivalent |
| K920410 | EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB | Feb 14, 1994 | Substantially Equivalent |
| K926423 | S/2(TM) STOPCOCK | Mar 23, 1993 | Substantially Equivalent |
| K921415 | IRRIGATION TUBING SET | Sep 4, 1992 | Substantially Equivalent |
| K921253 | INSTRUMENT IRRIGATION PUMP | Aug 6, 1992 | Substantially Equivalent |
| K915458 | URETEROSCOPE | Jan 30, 1992 | Substantially Equivalent |