Visera Hysterovideoscope Olympus HYF Type V

Hysteroscope (and Accessories)

Olympus Medical Systems Corporation

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Visera Hysterovideoscope Olympus Hyf Type V.

Pre-market Notification Details

• Device ID: K221557
• 510k Number: K221557
• Device Name: Visera Hysterovideoscope Olympus HYF Type V
• Classification: Hysteroscope (and Accessories)
• Applicant: Olympus Medical Systems Corporation 2951 Ishikawa-cho, Hachioji-shi Tokyo, JP
• Contact: Toshio Nakamura
• Correspondent: Gary Brennan; Olympus Corporation Of The Americas 800 West Park Drive Westborough, MA 01581
• Product Code: HIH
• CFR Regulation Number: 884.1690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-05-31
• Decision Date: 2022-09-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04953170411564	K221557	000
04953170340185	K221557	000
04953170458439	K221557	000