K-number	K862364
Device name	NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
Applicant	Swemed Laboratories, Inc.
Product code	HEM
Device class	Class II
Decision date	Aug 19, 1986
Decision	Substantially Equivalent for Some Indications
Regulation	884.2225

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 →

NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)

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