K-number	K930218
Device name	SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
Applicant	Concord/Portex
Product code	MAJ
Device class	Class II
Decision date	Jul 27, 1993
Decision	Substantially Equivalent
Regulation	868.5120

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 →

SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES

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