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FDA 510(k)

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection

N.º K: K232046 · 2023-10-06

SolicitanteXeridiem Medical Devices, A Spectrum Plastics Group Company
Fecha de decisión2023-10-06
Código de productoPIF
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection is the device name listed in this FDA 510(k) record. The listed applicant is Xeridiem Medical Devices, A Spectrum Plastics Group Company. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232046. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection?

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Xeridiem Medical Devices, A Spectrum Plastics Group Company. The 510(k) number is K232046.

When did Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection receive FDA 510(k) clearance?

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232046.

Who is the listed applicant for Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection?

The FDA 510(k) record lists Xeridiem Medical Devices, A Spectrum Plastics Group Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection?

The FDA product code for Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection is PIF.

Ensayos clínicos relacionados

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Otros registros que enlistan a Xeridiem Medical Devices, A Spectrum Plastics Group Company 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.

K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit

Dispositivos relacionados (Código: PIF)

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.

K260110danumed Extension Set for Gastrostomy ButtonDanumed Medizintechnik GmbHK253715Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)Maquet Critical Care ABK254170Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone , Ltd.K242917Enteral Drainage System, Enteral Medicine strawHMC Premedical S.p.A.K250481Extension Feeding Set with ENFit™ ConnectorsSKY Medical, a.s.K240052Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd.

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.

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