OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM

System, Imaging, Gastrointestinal, Wireless, Capsule

OLYMPUS MEDICAL SYSTEMS CORP.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Olympus Small Intestinal Capsule Endoscope System.

Pre-market Notification Details

• Device ID: K123421
• 510k Number: K123421
• Device Name: OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
• Classification: System, Imaging, Gastrointestinal, Wireless, Capsule
• Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610
• Contact: Daphney Germain-kolawole
• Correspondent: Daphney Germain-kolawole; OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610
• Product Code: NEZ
• CFR Regulation Number: 876.1300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-06
• Decision Date: 2013-04-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04953170333330	K123421	000
04953170360824	K123421	000
04953170328244	K123421	000
04953170328268	K123421	000
04953170328299	K123421	000
04953170328312	K123421	000
04953170328350	K123421	000
04953170328381	K123421	000
04953170333316	K123421	000
04953170360817	K123421	000