Name: Predicase
Price: 199 USD

K-number	K183188
Device name	Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
Applicant	Richard Wolf Medical Instruments Corporation
Product code	FGB
Device class	Class II
Decision date	May 3, 2019
Decision	Substantially Equivalent
Regulation	876.1500

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 →

Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF

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