FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
EL27-Compact; Sterile EHL-Probes
K Number: K230488
·
Decision Aug 31, 2023
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
60
Applicant Total
1
Review Days
189
Basic Information
- Device Name
- EL27-Compact; Sterile EHL-Probes
- K Number
- K230488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Walz Elektronik GmbH
- Date Received
- February 23, 2023
- Decision Date
- August 31, 2023
- 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 |
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