Name: Predicase
Price: 199 USD

K-number	K213171
Device name	Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
Applicant	Meditrina, Inc.
Product code	HIH
Device class	Class II
Decision date	May 26, 2022
Decision	Substantially Equivalent
Regulation	884.1690

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 →

Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)

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