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

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Single Use Electrosurgical Knife Series, Model Kd-610l, Kd-611l, Kd-620lr, Kd-630l, Kf-640l.

Pre-market Notification Details

• Device ID: K092309
• 510k Number: K092309
• Device Name: SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
• Classification: Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
• Applicant: OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034
• Contact: Stacy Abbatiello Kluesner
• Correspondent: Stacy Abbatiello Kluesner; OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034
• Product Code: KNS
• CFR Regulation Number: 876.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-30
• Decision Date: 2009-10-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14953170325936	K092309	000
14953170462334	K092309	000
14953170453998	K092309	000
14953170453981	K092309	000
14953170453974	K092309	000
14953170453967	K092309	000
14953170453950	K092309	000
14953170453943	K092309	000
14953170453936	K092309	000
14953170208406	K092309	000
14953170208413	K092309	000
14953170208420	K092309	000
14953170325899	K092309	000
14953170265782	K092309	000
14953170265775	K092309	000
14953170265768	K092309	000
14953170251518	K092309	000
14953170251501	K092309	000
14953170225960	K092309	000
14953170208543	K092309	000
14953170453929	K092309	000