FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
K Number: K970595
·
Decision Oct 24, 1997
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
35
Applicant Total
14
Review Days
248
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Basic Information
- Device Name
- CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP
- K Number
- K970595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Circon Video
- Date Received
- February 18, 1997
- Decision Date
- October 24, 1997
- Product Code
- FEN
- 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 |
|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Circon Video
| K Number | Device Name | ||
|---|---|---|---|
| K012758 | URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, | Apr 9, 2002 | Substantially Equivalent |
| K011876 | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 | Jan 8, 2002 | Substantially Equivalent |
| K011849 | MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS | Dec 10, 2001 | Substantially Equivalent |
| K012929 | FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 | Nov 19, 2001 | Substantially Equivalent |
| K012951 | APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE | Nov 9, 2001 | Substantially Equivalent |
| K012925 | DUR-8, MODELS DUR-8 | Nov 7, 2001 | Substantially Equivalent |
| K012265 | METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 | Oct 17, 2001 | Substantially Equivalent |
| K012153 | LOWSLEY SUPRAPUBIC TRACTOR | Sep 19, 2001 | Substantially Equivalent |
| K011848 | CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE | Sep 11, 2001 | Substantially Equivalent |
| K914883 | CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG | Jan 15, 1993 | Substantially Equivalent |