FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Shock Pulse-SE Lithotripsy System CYBERWAND II
K Number: K142428
·
Decision Nov 13, 2014
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
13
Applicant Total
7
Review Days
76
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Basic Information
- Device Name
- Shock Pulse-SE Lithotripsy System CYBERWAND II
- K Number
- K142428
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cybersonics, Inc.
- Date Received
- August 29, 2014
- Decision Date
- November 13, 2014
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FEO), ordered by most recent decision date.
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ShockPulse-SE Lithotripsy System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Cybersonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K171024 | ShockPulse-SE Lithotripsy System | Aug 21, 2017 | Substantially Equivalent |
| K132795 | CYBERWAND STERILE PROBE SET | Nov 26, 2013 | Substantially Equivalent |
| K120303 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | Jun 5, 2012 | Substantially Equivalent |
| K102169 | CYBERWAND LITHOTRIPTER | Aug 30, 2010 | Substantially Equivalent |
| K072422 | CYBERWAND STERILE PADS, MODEL: CW-RBPBX | Oct 24, 2007 | Substantially Equivalent |
| K052135 | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER | Dec 20, 2005 | Substantially Equivalent |