FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB
K Number: K920410
·
Decision Feb 14, 1994
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
7
Review Days
745
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
- EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB
- K Number
- K920410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Psi Medical Products, Inc.
- Date Received
- January 31, 1992
- Decision Date
- February 14, 1994
- 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
Other Clearances by Psi Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931779 | EHL PULSE GENERATOR | Feb 15, 1994 | Substantially Equivalent |
| K915459 | FLOWMATE HAND PUMP | Feb 15, 1994 | Substantially Equivalent |
| K926423 | S/2(TM) STOPCOCK | Mar 23, 1993 | Substantially Equivalent |
| K921415 | IRRIGATION TUBING SET | Sep 4, 1992 | Substantially Equivalent |
| K921253 | INSTRUMENT IRRIGATION PUMP | Aug 6, 1992 | Substantially Equivalent |
| K915458 | URETEROSCOPE | Jan 30, 1992 | Substantially Equivalent |