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FDA 510(k)

Instrument Case

K-Number: K231604 · 2023-08-24

ApplicantCochlear Americas
Decision Date2023-08-24
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Instrument Case is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K231604. 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?

Instrument Case is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Cochlear Americas. The 510(k) number is K231604.

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

Instrument Case received FDA 510(k) clearance on 2023-08-24, under 510(k) number K231604.

Who is the listed applicant for Instrument Case?

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 Instrument Case?

The FDA product code for Instrument Case is KCT.

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

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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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