Cochlear Osia® System +6 more— 510(k) K231204
Substantially EquivalentCochlear
FDA 510(k) clearance K231204 for Cochlear Osia® System +6 more, Substantially Equivalent on 2023-08-18. Applicant: Cochlear. Device class: 2.
Clearance details
- Device name as filed
- 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
- Applicant
- Cochlear
- 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
- Lone Tree, 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
- K220922 — Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
- K201983 — BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
More clearances from Cochlear
view allAdverse 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.