FDA 510(k)

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

Номер K: K193325 · 2020-03-13

Дата решения2020-03-13

Код продуктаKNT

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches is the device name listed in this FDA 510(k) record. The listed applicant is Prosys International, Ltd.. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K193325. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches?

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is Prosys International, Ltd.. The 510(k) number is K193325.

When did Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches receive FDA 510(k) clearance?

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches received FDA 510(k) clearance on 2020-03-13, under 510(k) number K193325.

Who is the listed applicant for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches?

The FDA 510(k) record lists Prosys International, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches?

The FDA product code for Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches is KNT.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: 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

Официальный источник

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