FDA.reportPublic FDA data

510(k) K240155

Device
Cochlear Osia System
Applicant
Cochlear Americas
510(k) number
K240155
Product code
PFO
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-18
Date received
2024-01-19
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
Whitney Alexander
Address
10350 Park Meadows Dr. Lone Tree CO US 80124 80124

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PFO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSOticon Medical AB2024-07-10
K231204Cochlear™ 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 AppCochlear2023-08-18
K220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitCochlear Americas2022-07-27
K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)Med-El Elektromedizinische Geraete GmbH2020-10-09
K200504BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 RemoteMed-El Elektromedizinische Geraete GmbH2020-07-29
K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsCochlear Americas2019-11-15
K191457BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)Med-El Elektromedizinische Geraete GmbH2019-09-18
K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsCochlear Americas2019-07-03
K183373BonebridgeMed-El Elektromedizinische Geraete GmbH2019-03-07
DEN170009BonebridgeMed-El Elektromedizinische Geraete GmbH2018-07-20