Name: Predicase
Price: 199 USD

K-number	K233140
Device name	Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
Applicant	Hygea Medical Technology Co., Ltd.
Product code	NEY
Device class	Class II
Decision date	Jan 31, 2024
Decision	Substantially Equivalent
Regulation	878.4400

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 →

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)

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