OLYMPUS OES LAPAROSCOPY SYSTEM

Laparoscope, General & Plastic Surgery

OLYMPUS CORP.

The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Oes Laparoscopy System.

Pre-market Notification Details

• Device ID: K923982
• 510k Number: K923982
• Device Name: OLYMPUS OES LAPAROSCOPY SYSTEM
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042
• Contact: Andrew Fleischacker
• Correspondent: Andrew Fleischacker; OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-08-07
• Decision Date: 1993-03-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14042761052693	K923982	000
04042761031110	K923982	000
04042761031103	K923982	000
04042761030861	K923982	000
04042761030854	K923982	000
04042761030847	K923982	000
04042761030830	K923982	000
04042761030823	K923982	000
04042761030816	K923982	000
04042761030809	K923982	000
04042761030793	K923982	000
04042761030786	K923982	000
04042761030779	K923982	000
04042761024419	K923982	000
04042761024372	K923982	000
04042761052658	K923982	000
04042761052641	K923982	000
04042761031134	K923982	000
04042761006125	K923982	000
04042761006156	K923982	000
04042761006163	K923982	000
04042761008792	K923982	000
04042761008785	K923982	000
04042761008778	K923982	000
04042761008761	K923982	000
04042761029759	K923982	000
04042761029599	K923982	000
04042761029582	K923982	000
04042761009515	K923982	000
04042761009508	K923982	000
04042761009492	K923982	000
04042761009485	K923982	000
04042761008983	K923982	000
04042761008969	K923982	000
04042761008860	K923982	000
04042761008815	K923982	000
04042761008808	K923982	000
04042761006194	K923982	000
04042761024402	K923982	000