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FDA 510(k)

Entuit 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

Número K: K180708 · 2018-10-18

RequerenteXeridiem Medical Devices, A Spectrum Plastics Group Company
Data da decisão2018-10-18
Código do produtoPIF
Comité consultivoGU
DecisãoUnknown

Resumo do dispositivo

Entuit 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 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 2018-10-18 under 510(k) number K180708. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Entuit 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?

Entuit 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 is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Xeridiem Medical Devices, A Spectrum Plastics Group Company. The 510(k) number is K180708.

When did Entuit 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 receive FDA 510(k) clearance?

Entuit 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 received FDA 510(k) clearance on 2018-10-18, under 510(k) number K180708.

Who is the listed applicant for Entuit 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?

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 Entuit 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?

The FDA product code for Entuit 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 is PIF.

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Outros registros que listam Xeridiem Medical Devices, A Spectrum Plastics Group Company como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection

Dispositivos Relacionados (Código: PIF)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.

Fonte oficial

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