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FDA 510(k)

BA310 Abutment, BIA310 Implant/Abutment

K-Number: K182116 · 2018-12-19

ApplicantCochlear Americas
Decision Date2018-12-19
Product CodeMAH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BA310 Abutment, BIA310 Implant/Abutment is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2018-12-19 under 510(k) number K182116. The device is classified under product code MAH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BA310 Abutment, BIA310 Implant/Abutment?

BA310 Abutment, BIA310 Implant/Abutment is a medical device that received FDA 510(k) clearance on 2018-12-19. The listed applicant is Cochlear Americas. The 510(k) number is K182116.

When did BA310 Abutment, BIA310 Implant/Abutment receive FDA 510(k) clearance?

BA310 Abutment, BIA310 Implant/Abutment received FDA 510(k) clearance on 2018-12-19, under 510(k) number K182116.

Who is the listed applicant for BA310 Abutment, BIA310 Implant/Abutment?

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 BA310 Abutment, BIA310 Implant/Abutment?

The FDA product code for BA310 Abutment, BIA310 Implant/Abutment is MAH.

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® SystemPMA P970051Implant, cochlearPMA P130016Cochlear implant with combined electrical stimulation and acoustic amplificationPMA P000015Implant, auditory brainstemPMA P890027Implant, cochlearPMA P840024Implant, cochlear

View all 17 devices →

Related Devices (Code: MAH)

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.

K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical ABK152820Ponto Bone Anchored Hearing SystemOticon Medical AB

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.

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