AEON Laparoscopic Instruments
K-Number: K192235 · 2019-10-11
ApplicantLexington Medical, Inc.
Decision Date2019-10-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AEON Laparoscopic Instruments is a medical device manufactured by Lexington Medical, Inc.. It received FDA 510(k) clearance on 2019-10-11 under approval number K192235. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AEON Laparoscopic Instruments?
AEON Laparoscopic Instruments is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Lexington Medical, Inc.. The 510(k) number is K192235.
When was AEON Laparoscopic Instruments approved by the FDA?
AEON Laparoscopic Instruments received FDA 510(k) clearance on 2019-10-11, under approval number K192235.
What company makes AEON Laparoscopic Instruments?
AEON Laparoscopic Instruments is manufactured by Lexington Medical, Inc..
What is the FDA product code for AEON Laparoscopic Instruments?
The FDA product code for AEON Laparoscopic Instruments is GEI.
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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.