Name: Predicase
Price: 199 USD

K-number	K092309
Device name	SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
Applicant	Olympus Medical Systems Corporation
Product code	KNS
Device class	Class II
Decision date	Oct 30, 2009
Decision	Substantially Equivalent
Regulation	876.4300

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 →

SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L

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