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FDA 510(k)

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C

K-Number: K250891 · 2025-06-06

ApplicantConvatec Limited
Decision Date2025-06-06
Product CodeFCM
Advisory CommitteeGU
DecisionUnknown

Device Summary

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C is a medical device manufactured by Convatec Limited. It received FDA 510(k) clearance on 2025-06-06 under approval number K250891. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C?

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by Convatec Limited. The 510(k) number is K250891.

When was Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C approved by the FDA?

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C received FDA 510(k) clearance on 2025-06-06, under approval number K250891.

What company makes Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C?

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C is manufactured by Convatec Limited.

What is the FDA product code for Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C?

The FDA product code for Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C is FCM.

Related Clinical Trials

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Related PubMed Literature

PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 31926779 Pigtail Catheter Insertion Error: Root Cause Analysis and Recommendations for Patient Safety. The Journal of emergency medicine (2020)

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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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