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 a medical device manufactured by Cochlear. It received FDA 510(k) clearance on 2023-03-21 under approval 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. It is manufactured by Cochlear. The 510(k) number is K223672.
When was Instrument Case P1340904 approved by the FDA?
Instrument Case P1340904 received FDA 510(k) clearance on 2023-03-21, under approval number K223672.
What company makes Instrument Case P1340904?
Instrument Case P1340904 is manufactured by Cochlear.
What is the FDA product code for Instrument Case P1340904?
The FDA product code for Instrument Case P1340904 is KCT.
Related Clinical Trials
NCT06642935
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss
ACTIVE_NOT_RECRUITING
NCT06100393
New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
ACTIVE_NOT_RECRUITING
NCT07262827
Investigating the Acceptance and Performance of Low Energy Audio Streaming in Nucleus 8 and Kanso 3 Sound Processors by Experienced Cochlear Implant Users
RECRUITING
NCT07287124
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
RECRUITING
NCT07033130
The Performance of Different Sound Paths in Adult NeuroZti CI-users
TERMINATED
NCT06894303
Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
RECRUITING
Other Devices by Cochlear
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 App
K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
Related Devices (Code: KCT)
K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG
K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc.
K160912Sterilization TraySTERIS Corporation
K161347Signia sterilization trayCovidien
K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc.
K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.
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.