FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
K Number: K850298
·
Decision Mar 5, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
13
Applicant Total
38
Review Days
40
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Basic Information
- Device Name
- ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
- K Number
- K850298
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cabot Medical Corp.
- Date Received
- January 24, 1985
- Decision Date
- March 5, 1985
- Product Code
- FEO
- 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 |
|---|---|---|---|
| FEO | Lithotriptor, Ultrasonic | FDA class 2 | Gastroenterology, Urology |
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| 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 |