K-number	K101889
Device name	DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE
Applicant	Pivotal Health Solutions
Product code	ITH
Device class	Class II
Decision date	Aug 27, 2010
Decision	Substantially Equivalent
Regulation	890.5900

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 →

DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE

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