Name: Predicase
Price: 199 USD

K-number	K071756
Device name	ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE
Applicant	Pointe Conception Medical, Inc.
Product code	GCJ
Device class	Class II
Decision date	Aug 15, 2007
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 →

ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE

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