K-number	K053250
Device name	ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
Applicant	Advanced Neuromodulation Systems
Product code	GZB
Device class	Class II
Decision date	Dec 15, 2005
Decision	Substantially Equivalent
Regulation	882.5880

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT

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