Name: Predicase
Price: 199 USD

K-number	K232665
Device name	GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)
Applicant	Convatec
Product code	EZD
Device class	Class II
Decision date	Jan 25, 2024
Decision	Substantially Equivalent
Regulation	876.5130

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

Everything you need for a 510(k) submission. Nothing you don't.