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FDA 510(k)

Instrument Case P1340904

K-Number: K223672 · 2023-03-21

ApplicantCochlear
Decision Date2023-03-21
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Instrument Case P1340904 is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear. It received FDA 510(k) clearance on 2023-03-21 under 510(k) number K223672. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Instrument Case P1340904?

Instrument Case P1340904 is a medical device that received FDA 510(k) clearance on 2023-03-21. The listed applicant is Cochlear. The 510(k) number is K223672.

When did Instrument Case P1340904 receive FDA 510(k) clearance?

Instrument Case P1340904 received FDA 510(k) clearance on 2023-03-21, under 510(k) number K223672.

Who is the listed applicant for Instrument Case P1340904?

The FDA 510(k) record lists Cochlear as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Instrument Case P1340904?

The FDA product code for Instrument Case P1340904 is KCT.

Related Clinical Trials

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.

NCT04741009Perimodiolar Implant Performance in Adults With Low-Frequency Residual HearingCOMPLETEDNCT05641155A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.COMPLETEDNCT05709223Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activationCOMPLETEDNCT06100393New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.ACTIVE_NOT_RECRUITINGNCT06293482Safety and Effectiveness of Cochlear Implantation in an Expanded Adult PopulationACTIVE_NOT_RECRUITINGNCT06424262Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)COMPLETED

Other records listing Cochlear 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.

K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBandK231204Cochlear™ 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

Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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