FDA 510(k)

Dispositivo de Gastrostomía Feeding Balón G-Tube AMT

N.º K: K222846 · 2023-12-18

SolicitanteApplied Medical Technology, Inc.

Fecha de decisión2023-12-18

Código de productoKNT

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

AMT G-Tube Balloon Gastrostomy Feeding Device is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-12-18 under 510(k) number K222846. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AMT G-Tube Balloon Gastrostomy Feeding Device?

AMT G-Tube Balloon Gastrostomy Feeding Device is a medical device that received FDA 510(k) clearance on 2023-12-18. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K222846.

When did AMT G-Tube Balloon Gastrostomy Feeding Device receive FDA 510(k) clearance?

AMT G-Tube Balloon Gastrostomy Feeding Device received FDA 510(k) clearance on 2023-12-18, under 510(k) number K222846.

Who is the listed applicant for AMT G-Tube Balloon Gastrostomy Feeding Device?

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

What is the FDA product code for AMT G-Tube Balloon Gastrostomy Feeding Device?

The FDA product code for AMT G-Tube Balloon Gastrostomy Feeding Device is KNT.

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Otros registros que enlistan a Applied Medical Technology, Inc. como solicitante

K252438Explant Express K240514Set de Catéter Suprapúbico de Bajo Profilo AMT y Drenaje K241111Paseador de Suturas AMT K202539Nutriglide(TM) Nasal Feeding Tube K193612Sistema de Entrega de Suturas AMT K183508Micro Transgastric-Jejunal Feeding Device

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Dispositivos relacionados (Código: KNT)

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd K243228Flexi-Seal AIR (with ENFit Connector)Convatec K242336hygh-tec Drainage IIAmb Medtec K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

Fuente oficial

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