Name: Predicase
Price: 199 USD

K-number	K232028
Device name	Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
Applicant	Iq Endoscopes Limited
Product code	FDS
Device class	Class II
Decision date	Nov 17, 2023
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 →

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)

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