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FDA 510(k)

AEON Endoscopic Stapler

K-Number: K182380 · 2018-11-28

ApplicantLexington Medical, Inc.
Decision Date2018-11-28
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AEON Endoscopic Stapler is a medical device manufactured by Lexington Medical, Inc.. It received FDA 510(k) clearance on 2018-11-28 under approval number K182380. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEON Endoscopic Stapler?

AEON Endoscopic Stapler is a medical device that received FDA 510(k) clearance on 2018-11-28. It is manufactured by Lexington Medical, Inc.. The 510(k) number is K182380.

When was AEON Endoscopic Stapler approved by the FDA?

AEON Endoscopic Stapler received FDA 510(k) clearance on 2018-11-28, under approval number K182380.

What company makes AEON Endoscopic Stapler?

AEON Endoscopic Stapler is manufactured by Lexington Medical, Inc..

What is the FDA product code for AEON Endoscopic Stapler?

The FDA product code for AEON Endoscopic Stapler is GDW.

Other Devices by Lexington Medical, Inc.

K171589AEON Endoscopic Stapler K180114AEON Retrieval Bag K173443AEON Endoscopic Stapler K192235AEON Laparoscopic Instruments K201882AEON Endoscopic Stapler K222210AEON Endoscopic Stapler

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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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