Name: Predicase
Price: 199 USD

K-number	K012573
Device name	CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC
Applicant	Getinge/Castle, Inc.
Product code	FLE
Device class	Class II
Decision date	Sep 5, 2001
Decision	Substantially Equivalent
Regulation	880.6880

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 →

CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC

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