FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
K Number: K242852
·
Decision Jun 13, 2025
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
94
Applicant Total
4
Review Days
266
Basic Information
- Device Name
- ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)
- K Number
- K242852
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1820
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- inomed Medizintechnik GmbH
- Date Received
- September 20, 2024
- Decision Date
- June 13, 2025
- Product Code
- ETN
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ETN | Stimulator, Nerve | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by inomed Medizintechnik GmbH
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|---|---|---|---|
| K233292 | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress | Oct 27, 2023 | Substantially Equivalent |
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