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FDA 510(k)

MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS

K-Number: K041058 · 2004-05-17

ApplicantMisonix, Inc.
Decision Date2004-05-17
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Misonix, Inc.. It received FDA 510(k) clearance on 2004-05-17 under 510(k) number K041058. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS?

MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-05-17. The listed applicant is Misonix, Inc.. The 510(k) number is K041058.

When did MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS receive FDA 510(k) clearance?

MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS received FDA 510(k) clearance on 2004-05-17, under 510(k) number K041058.

Who is the listed applicant for MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS?

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

What is the FDA product code for MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS?

The FDA product code for MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS is QPB.

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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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