Decision Date2024-04-18
Product CodePFO
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
Cochlear Osia System is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2024-04-18 under 510(k) number K240155. The device is classified under product code PFO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cochlear Osia System?
Cochlear Osia System is a medical device that received FDA 510(k) clearance on 2024-04-18. The listed applicant is Cochlear Americas. The 510(k) number is K240155.
When did Cochlear Osia System receive FDA 510(k) clearance?
Cochlear Osia System received FDA 510(k) clearance on 2024-04-18, under 510(k) number K240155.
Who is the listed applicant for Cochlear Osia System?
The FDA 510(k) record lists Cochlear Americas as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cochlear Osia System?
The FDA product code for Cochlear Osia System is PFO.
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Other records listing Cochlear Americas as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K260902Cochlear™ 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® SystemK231604Instrument CaseK220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitK212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppK202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart AppK191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments View all 18 devices →
Related Devices (Code: PFO)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K260902Cochlear™ 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® SystemCochlear AmericasK240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSOticon Medical ABK231204Cochlear™ 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 AppCochlearK220922Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI KitCochlear AmericasK201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)Med-El Elektromedizinische Geraete GmbHK200504BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 RemoteMed-El Elektromedizinische Geraete GmbH
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.