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FDA 510(k)

LIPOEZE LASER ASSISTED ASPIRATION CANNULA

K-Number: K091800 · 2009-09-23

ApplicantCurve Medical
Decision Date2009-09-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIPOEZE LASER ASSISTED ASPIRATION CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Curve Medical. It received FDA 510(k) clearance on 2009-09-23 under 510(k) number K091800. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPOEZE LASER ASSISTED ASPIRATION CANNULA?

LIPOEZE LASER ASSISTED ASPIRATION CANNULA is a medical device that received FDA 510(k) clearance on 2009-09-23. The listed applicant is Curve Medical. The 510(k) number is K091800.

When did LIPOEZE LASER ASSISTED ASPIRATION CANNULA receive FDA 510(k) clearance?

LIPOEZE LASER ASSISTED ASPIRATION CANNULA received FDA 510(k) clearance on 2009-09-23, under 510(k) number K091800.

Who is the listed applicant for LIPOEZE LASER ASSISTED ASPIRATION CANNULA?

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

What is the FDA product code for LIPOEZE LASER ASSISTED ASPIRATION CANNULA?

The FDA product code for LIPOEZE LASER ASSISTED ASPIRATION CANNULA is GEX. This falls under the Gastroenterology category.

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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.

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