FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
K Number: K191457
·
Decision Sep 18, 2019
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
10
Applicant Total
6
Review Days
110
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Basic Information
- Device Name
- BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
- K Number
- K191457
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3340
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Med-El Elektromedizinische Geraete GmbH
- Date Received
- May 31, 2019
- Decision Date
- September 18, 2019
- Product Code
- PFO
- 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 |
|---|---|---|---|
| PFO | Active Implantable Bone Conduction Hearing System | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Med-El Elektromedizinische Geraete GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) | Oct 9, 2020 | Substantially Equivalent |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | Jul 29, 2020 | Substantially Equivalent |
| K183373 | Bonebridge | Mar 7, 2019 | Substantially Equivalent |
| DEN170009 | Bonebridge | Jul 20, 2018 | Unknown |
| K172460 | ADHEAR System | Apr 27, 2018 | Substantially Equivalent |