FDA 510(k)

XNY Disposable Gastric Calibration Tube

N.º K: K250389 · 2025-04-10

SolicitanteChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd

Fecha de decisión2025-04-10

Código de productoKNT

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

XNY Disposable Gastric Calibration Tube is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. It received FDA 510(k) clearance on 2025-04-10 under 510(k) number K250389. 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 XNY Disposable Gastric Calibration Tube?

XNY Disposable Gastric Calibration Tube is a medical device that received FDA 510(k) clearance on 2025-04-10. The listed applicant is Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. The 510(k) number is K250389.

When did XNY Disposable Gastric Calibration Tube receive FDA 510(k) clearance?

XNY Disposable Gastric Calibration Tube received FDA 510(k) clearance on 2025-04-10, under 510(k) number K250389.

Who is the listed applicant for XNY Disposable Gastric Calibration Tube?

The FDA 510(k) record lists Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XNY Disposable Gastric Calibration Tube?

The FDA product code for XNY Disposable Gastric Calibration Tube is KNT.

Ensayos clínicos relacionados

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Otros registros que enlistan a Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd como solicitante

K190029Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge

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.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 K241169Entarik NI Feeding Tube SystemGravitas Medical, Inc.

Fuente oficial

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