Sonotome

FDA 510(k) K990572 · Sonokinetics, Inc.

Substantially Equivalent

510(k) numberK990572

Submission

Device name
Sonotome
Applicant
Sonokinetics, Inc.
Hopkinton, MA, US
Received
February 23, 1999
Decision date
May 21, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LFL – Instrument, Ultrasonic Surgical
Device class
Unclassified

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K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional Integra LifeSciences Corporation07/11/2023SE
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Questions and answers

When was Sonotome cleared by the FDA?

Sonotome (K990572) received a 510(k) decision of Substantially Equivalent on May 21, 1999, 87 days after the submission was received.

What is the product code of K990572?

The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.