Single Use Balloon Dilator V (with Knife)

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Balloon Dilator V (with Knife).

Pre-market Notification Details

• Device ID: K193039
• 510k Number: K193039
• Device Name: Single Use Balloon Dilator V (with Knife)
• Classification: Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
• Applicant: Olympus Medical Systems Corp. 2951 Ishikawa-machi Hachioji-shi, JP 192-8507
• Contact: Toshiyuki Nakajima
• Correspondent: Sheri L. Musgnung; Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034 -0610
• Product Code: KNS
• CFR Regulation Number: 876.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-10-31
• Decision Date: 2019-12-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14953170414128	K193039	000
14953170414104	K193039	000
14953170414081	K193039	000