510(k) K190589
- Device
- Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
- Applicant
- Cochlear Americas
- 510(k) number
- K190589
- Product code
- PFO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-03
- Date received
- 2019-03-07
- Regulation
- 874.3340
- Classification name
- Active Implantable Bone Conduction Hearing System
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Laura Blair
- Address
- 13059 E Peakview Ave. Centennial CO US 80111 80111
FDA Registration Numbers#
- 9710014
- 3014579188
- 3006405073
- 3013177549
- 3007367732
- 3009307953
- 3020283264
- 3032579106
- 3005900820
- 3005210579
- 3009092818
- 3002808022
- 3006174295
- 9613646
- 9616024
Source Documents#
Other 510(k) Records For Product Code PFO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | Oticon Medical AB | 2024-07-10 |
| K240155 | Cochlear Osia System | Cochlear Americas | 2024-04-18 |
| K231204 | Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App | Cochlear | 2023-08-18 |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit | Cochlear Americas | 2022-07-27 |
| K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) | Med-El Elektromedizinische Geraete GmbH | 2020-10-09 |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | Med-El Elektromedizinische Geraete GmbH | 2020-07-29 |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments | Cochlear Americas | 2019-11-15 |
| K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) | Med-El Elektromedizinische Geraete GmbH | 2019-09-18 |
| K183373 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | 2019-03-07 |
| DEN170009 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | 2018-07-20 |
Legacy Summary#
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FDA Review#
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