Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments— 510(k) K190589
Substantially EquivalentCochlear Americas
FDA 510(k) clearance K190589 for Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments, Substantially Equivalent on 2019-07-03. Applicant: Cochlear Americas. Device class: 2.
Clearance details
- Applicant
- Cochlear Americas
- Product code
- Code PFO
- Device class
- Class 2
- Regulation
- 21 CFR 874.3340
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Centennial, CO, US
Recent devices under product code PFO
view all- K260902 — Cochlear Osia® 3(I) Sound Processor +6 more
- K240614 — Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
- K240155 — Cochlear Osia System
- K231204 — Cochlear Osia® System +6 more
- K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
More clearances from Cochlear Americas
view all- K231604 — Instrument Case
- K212136 — Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
- K202048 — Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
- K191921 — Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
- K182116 — BA310 Abutment, BIA310 Implant/Abutment
Adverse events under product code PFO
product code PFO- Injury
- 2,752
- Total
- 2,752
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.