FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
K Number: K132672
·
Decision Sep 23, 2013
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
55
Applicant Total
6
Review Days
27
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Basic Information
- Device Name
- EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
- K Number
- K132672
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5990
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dornier Medtech America
- Date Received
- August 27, 2013
- Decision Date
- September 23, 2013
- Product Code
- LNS
- 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 |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K233380 | TRIDENT Mobile Fluoroscopy System | Jun 26, 2024 | Substantially Equivalent |
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| K170122 | Delta III Lithotripter | Jun 28, 2017 | Substantially Equivalent |
| K151298 | Gemini XXP-HP | Jul 30, 2015 | Substantially Equivalent |