Name: Predicase
Price: 199 USD

K-number	K234107
Device name	Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
Applicant	Laborie Medical Technologies, Corp.
Product code	KLA
Device class	Class II
Decision date	Apr 23, 2024
Decision	Substantially Equivalent
Regulation	876.1725

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 →

Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)

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

Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)