FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
K Number: K092033
·
Decision Apr 30, 2010
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
1
Review Days
298
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
- K Number
- K092033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elmed USA
- Date Received
- July 6, 2009
- Decision Date
- April 30, 2010
- Product Code
- FFK
- 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 |
|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FFK), ordered by most recent decision date.
Electrohydraulic Lithotriptor (TCS-B3-II)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EL27-Compact; Sterile EHL-Probes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
URO-TOUCH 9 French Probe
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Swiss LithoClast Trilogy
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UreTron PF Series Probe
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology