FDA Product Code
FDA Product Code PFO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3340
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System | Cochlear Americas | 2026-07-10 | Traditional | PDF ↗ |
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | Oticon Medical AB | 2024-07-10 | Traditional | PDF ↗ |
| K240155 | Cochlear Osia System | Cochlear Americas | 2024-04-18 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | Med-El Elektromedizinische Geraete GmbH | 2020-07-29 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments | Cochlear Americas | 2019-07-03 | Traditional | PDF ↗ |
| K183373 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | 2019-03-07 | Traditional | PDF ↗ |
| DEN170009 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | 2018-07-20 | Direct | — |
Product code PFO · Class II · Ear, Nose, Throat. Data: openFDA.