AEON Retrieval Bag
K-Number: K180114 · 2018-03-27
ApplicantLexington Medical, Inc.
Decision Date2018-03-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
AEON Retrieval Bag is a medical device manufactured by Lexington Medical, Inc.. It received FDA 510(k) clearance on 2018-03-27 under approval number K180114. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AEON Retrieval Bag?
AEON Retrieval Bag is a medical device that received FDA 510(k) clearance on 2018-03-27. It is manufactured by Lexington Medical, Inc.. The 510(k) number is K180114.
When was AEON Retrieval Bag approved by the FDA?
AEON Retrieval Bag received FDA 510(k) clearance on 2018-03-27, under approval number K180114.
What company makes AEON Retrieval Bag?
AEON Retrieval Bag is manufactured by Lexington Medical, Inc..
What is the FDA product code for AEON Retrieval Bag?
The FDA product code for AEON Retrieval Bag is GCJ.
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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.