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FDA 510(k)

Flexi-Seal AIR (with ENFit Connector)

K-Number: K243228 · 2025-03-28

ApplicantConvatec
Decision Date2025-03-28
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexi-Seal AIR (with ENFit Connector) is a medical device manufactured by Convatec. It received FDA 510(k) clearance on 2025-03-28 under approval number K243228. 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 AIR (with ENFit Connector)?

Flexi-Seal AIR (with ENFit Connector) is a medical device that received FDA 510(k) clearance on 2025-03-28. It is manufactured by Convatec. The 510(k) number is K243228.

When was Flexi-Seal AIR (with ENFit Connector) approved by the FDA?

Flexi-Seal AIR (with ENFit Connector) received FDA 510(k) clearance on 2025-03-28, under approval number K243228.

What company makes Flexi-Seal AIR (with ENFit Connector)?

Flexi-Seal AIR (with ENFit Connector) is manufactured by Convatec.

What is the FDA product code for Flexi-Seal AIR (with ENFit Connector)?

The FDA product code for Flexi-Seal AIR (with ENFit Connector) is KNT.

Other Devices by Convatec

K162906Flexi-Seal PROTECT Fecal Management System K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) K250699Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)

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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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