FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
4.5 F LITHOTRIPTOR ELECTRODE
K Number: K830086
·
Decision Feb 9, 1983
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
33
Review Days
29
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
- 4.5 F LITHOTRIPTOR ELECTRODE
- K Number
- K830086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Monaghan Medical Corp.
- Date Received
- January 11, 1983
- Decision Date
- February 9, 1983
- 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 Monaghan Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K123945 | STRIVE DUAL ZONE PEAK FLOW METER | Apr 17, 2013 | Substantially Equivalent |
| K031514 | MODIFICATION TO TRUPEAK PEAK FLOW METER | May 23, 2003 | Substantially Equivalent |
| K023097 | TRUEZONE PEAK FLOW METER | Mar 7, 2003 | Substantially Equivalent |
| K012939 | AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER | Sep 28, 2001 | Substantially Equivalent |
| K991212 | MODIFICATION TO TRUZONE PEAK FLOW METER | Jul 1, 1999 | Substantially Equivalent |
| K964130 | AEROGEAR ASTHMA ACTION KIT | Jan 10, 1997 | Substantially Equivalent |
| K963089 | TRUZONE PEAK FLOW METER | Nov 6, 1996 | Substantially Equivalent |
| K963095 | TRUPEAK PEAK FLOW METER | Nov 4, 1996 | Substantially Equivalent |
| K955234 | TRUPEAK PEAK FLOW METER | Mar 18, 1996 | Substantially Equivalent |
| K955262 | TRUZONE PEAK FLOW METER | Mar 7, 1996 | Substantially Equivalent |