K-number	K132264
Device name	PRIMADO2 TOTAL SURGICAL SYSTEM
Applicant	Nakanishi, Inc.
Product code	HBC
Device class	Class II
Decision date	Dec 17, 2013
Decision	Substantially Equivalent
Regulation	882.4360

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 →

PRIMADO2 TOTAL SURGICAL SYSTEM

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