FDA 510(k)

AEON Endoscopic Powered Stapler (Courte/AEPH060); AEON Endoscopic Powered Stapler (Moyenne/AEPH160); AEON Endoscopic Powered Stapler (Longue/AEPH260)

Numéro K : K234039 · 2024-05-07

Date de décision2024-05-07

Code produitGAG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) 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 2024-05-07 under 510(k) number K234039. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)?

AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) is a medical device that received FDA 510(k) clearance on 2024-05-07. The listed applicant is Lexington Medical, Inc.. The 510(k) number is K234039.

When did AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) receive FDA 510(k) clearance?

AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) received FDA 510(k) clearance on 2024-05-07, under 510(k) number K234039.

Who is the listed applicant for AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)?

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 Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)?

The FDA product code for AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260) is GAG.

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Source officielle

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