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FDA 510(k)

AEON Retrieval Bag

K-Number: K180114 · 2018-03-27

Decision Date2018-03-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AEON Retrieval Bag is the device name listed in this FDA 510(k) record. The listed applicant is Lexington Medical, Inc.. It received FDA 510(k) clearance on 2018-03-27 under 510(k) 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. The listed applicant is Lexington Medical, Inc.. The 510(k) number is K180114.

When did AEON Retrieval Bag receive FDA 510(k) clearance?

AEON Retrieval Bag received FDA 510(k) clearance on 2018-03-27, under 510(k) number K180114.

Who is the listed applicant for AEON Retrieval Bag?

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

What is the FDA product code for AEON Retrieval Bag?

The FDA product code for AEON Retrieval Bag is GCJ.

Other records listing Lexington Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 9 devices →

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.