FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
TubaVent Balloon Dilatation System
K Number: K223542
·
Decision Aug 3, 2023
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
8
Applicant Total
1
Review Days
251
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Basic Information
- Device Name
- TubaVent Balloon Dilatation System
- K Number
- K223542
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4180
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spiggle & Theis Medizintechnik GmbH
- Date Received
- November 25, 2022
- Decision Date
- August 3, 2023
- Product Code
- PNZ
- 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 |
|---|---|---|---|
| PNZ | Eustachian Tube Balloon Dilation Device | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PNZ), ordered by most recent decision date.
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