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FDA 510(k)

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

K-Number: K190114 · 2019-04-30

ApplicantConvatec Limited
Decision Date2019-04-30
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) is a medical device manufactured by Convatec Limited. It received FDA 510(k) clearance on 2019-04-30 under approval number K190114. 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 Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)?

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) is a medical device that received FDA 510(k) clearance on 2019-04-30. It is manufactured by Convatec Limited. The 510(k) number is K190114.

When was Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) approved by the FDA?

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) received FDA 510(k) clearance on 2019-04-30, under approval number K190114.

What company makes Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)?

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) is manufactured by Convatec Limited.

What is the FDA product code for Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)?

The FDA product code for Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) is KNT.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 40061911 Engineering a Quality Management System for Academic Research: Navigating Challenges to Comply with the New Medical Device Regulations in Europe. Medical devices (Auckland, N.Z.) (2025)

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Official Source

View on FDA Database →

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

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