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FDA 510(k)

Sonicision Cordless Ultrasonic Dissection Device

K-Number: K153371 · 2016-03-28

ApplicantCovidien, LLC
Decision Date2016-03-28
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Sonicision Cordless Ultrasonic Dissection Device is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2016-03-28 under 510(k) number K153371. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonicision Cordless Ultrasonic Dissection Device?

Sonicision Cordless Ultrasonic Dissection Device is a medical device that received FDA 510(k) clearance on 2016-03-28. The listed applicant is Covidien, LLC. The 510(k) number is K153371.

When did Sonicision Cordless Ultrasonic Dissection Device receive FDA 510(k) clearance?

Sonicision Cordless Ultrasonic Dissection Device received FDA 510(k) clearance on 2016-03-28, under 510(k) number K153371.

Who is the listed applicant for Sonicision Cordless Ultrasonic Dissection Device?

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

What is the FDA product code for Sonicision Cordless Ultrasonic Dissection Device?

The FDA product code for Sonicision Cordless Ultrasonic Dissection Device is LFL.

Other records listing Covidien, LLC 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: LFL)

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.