FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS
K Number: K951972
·
Decision Jul 21, 1995
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
18
Applicant Total
38
Review Days
85
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Basic Information
- Device Name
- CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHS
- K Number
- K951972
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cabot Medical Corp.
- Date Received
- April 27, 1995
- Decision Date
- July 21, 1995
- Product Code
- FBO
- 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 |
|---|---|---|---|
| FBO | Cystourethroscope | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FBO), ordered by most recent decision date.
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
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FDA Class 2
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FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
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KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
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FDA Class 2
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ANCHORAGE SCOPE, MODEL 000003
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FDA Class 2
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KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Cabot Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K960148 | CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT | Mar 25, 1996 | Substantially Equivalent |
| K946109 | CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS | Nov 21, 1995 | Substantially Equivalent |
| K951714 | CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER | Jul 11, 1995 | Substantially Equivalent |
| K941743 | CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP | Apr 19, 1995 | Substantially Equivalent |
| K934115 | 3000 ELECTRONIC INSUFFLATOR MODIFICATION | Mar 15, 1995 | Substantially Equivalent |
| K932293 | CABOT MEDICAL BIPOLAR CUTTING FORCEPS | Jul 27, 1994 | Substantially Equivalent |
| K930954 | THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV | Jun 30, 1994 | Substantially Equivalent |
| K932626 | CABOT MEDICAL SURGIFLEX(R) SUCTION-IRRIGATION PROB | Jun 8, 1994 | Substantially Equivalent |
| K935786 | CORSON AND NEZHAT SUCTION/IRRIGATION PROBES | May 19, 1994 | Substantially Equivalent |
| K924631 | CABOT MEDICAL UTERINE RESECTOSCOPE | May 16, 1994 | Substantially Equivalent |