K-number	K080852
Device name	KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
Applicant	KARL STORZ Endoscopy-America, Inc.
Product code	HIF
Device class	Class II
Decision date	Mar 30, 2009
Decision	Substantially Equivalent
Regulation	884.1730

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 →

KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1

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