Name: Predicase
Price: 199 USD

K-number	K231666
Device name	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
Applicant	FUJIFILM Healthcare Americas Corporation
Product code	ITX
Device class	Class II
Decision date	Dec 13, 2023
Decision	Substantially Equivalent
Regulation	892.1570

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 →

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)

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