FDA 510(k)

AEON® Endoscopic Powered Stapler

N.º K: K251482 · 2025-07-11

Fecha de decisión2025-07-11

Código de productoGAG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

AEON™ Endoscopic Powered Stapler 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 2025-07-11 under 510(k) number K251482. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AEON™ Endoscopic Powered Stapler?

AEON™ Endoscopic Powered Stapler is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Lexington Medical, Inc.. The 510(k) number is K251482.

When did AEON™ Endoscopic Powered Stapler receive FDA 510(k) clearance?

AEON™ Endoscopic Powered Stapler received FDA 510(k) clearance on 2025-07-11, under 510(k) number K251482.

Who is the listed applicant for AEON™ Endoscopic Powered Stapler?

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?

The FDA product code for AEON™ Endoscopic Powered Stapler is GAG.

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Otros registros que enlistan a Lexington Medical, Inc. como solicitante

K234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)K222210AEON Endoscopic Stapler K201882AEON Endoscopic Stapler K192235AEON Laparoscopic Instruments K182380AEON Endoscopic Stapler K180114AEON Retrieval Bag

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: GAG)

K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)Covidien, LLC K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)Ethicon Endo-Surgery, LLC K234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)Lexington Medical, Inc.K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien

Fuente oficial

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