FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ERBEJET® 2 System
K Number: K231023
·
Decision Jun 15, 2023
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
52
Applicant Total
16
Review Days
65
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Basic Information
- Device Name
- ERBEJET® 2 System
- K Number
- K231023
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5475
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Erbe Elektromedizin GmbH
- Date Received
- April 11, 2023
- Decision Date
- June 15, 2023
- Product Code
- FQH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FQH | Lavage, Jet | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K243451 | FiAPC plus probes | Mar 21, 2025 | Substantially Equivalent |
| K242044 | FiAPC plus probes | Aug 26, 2024 | Substantially Equivalent |
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| K232033 | HYBRIDknife® flex | Nov 29, 2023 | Substantially Equivalent |
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