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FDA 510(k)

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

K-Number: K193325 · 2020-03-13

ApplicantProsys International, Ltd.
Decision Date2020-03-13
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Prosys International, Ltd.. The 510(k) number is K193325.

When was Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches approved by the FDA?

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

What company makes Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches?

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches is manufactured by Prosys International, Ltd..

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.

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Related PubMed Literature

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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