Name: Predicase
Price: 199 USD

K-number	K252646
Device name	Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
Applicant	Olympus Medical Systems Corp.
Product code	FCG
Device class	Class II
Decision date	Oct 24, 2025
Decision	Substantially Equivalent
Regulation	876.1075

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

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 →

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

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