Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)

N.º K: K243276 · 2025-02-25

SolicitanteEthicon Endo-Surgery, LLC
Fecha de decisión2025-02-25
Código de productoGDW
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2025-02-25 under 510(k) number K243276. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)?

ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) is a medical device that received FDA 510(k) clearance on 2025-02-25. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K243276.

When did ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) receive FDA 510(k) clearance?

ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) received FDA 510(k) clearance on 2025-02-25, under 510(k) number K243276.

Who is the listed applicant for ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)?

The FDA 510(k) record lists Ethicon Endo-Surgery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)?

The FDA product code for ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) is GDW.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Ethicon Endo-Surgery, LLC como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)

Ver todos los 35 dispositivos →

Dispositivos relacionados (Código: GDW)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)Ethicon Endo-Surgery, LLCK253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter ReloadsCovidien (Part of Medtronic)K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)Ethicon Endo-Surgery, LLCK250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)Ethicon Endo-Surgery, LLCK241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)Ethicon Endo-Surgery, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑