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FDA 510(k)

Sonicision Reusable Sterilization Tray

K-Number: K180915 · 2018-07-17

ApplicantCovidien
Decision Date2018-07-17
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sonicision Reusable Sterilization Tray is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2018-07-17 under 510(k) number K180915. 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 Sonicision Reusable Sterilization Tray?

Sonicision Reusable Sterilization Tray is a medical device that received FDA 510(k) clearance on 2018-07-17. The listed applicant is Covidien. The 510(k) number is K180915.

When did Sonicision Reusable Sterilization Tray receive FDA 510(k) clearance?

Sonicision Reusable Sterilization Tray received FDA 510(k) clearance on 2018-07-17, under 510(k) number K180915.

Who is the listed applicant for Sonicision Reusable Sterilization Tray?

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

What is the FDA product code for Sonicision Reusable Sterilization Tray?

The FDA product code for Sonicision Reusable Sterilization Tray is KCT.

Other records listing Covidien 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.

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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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.