SONOPSY

Biopsy Needle

HAKKO MEDICAL CO., LTD.

The following data is part of a premarket notification filed by Hakko Medical Co., Ltd. with the FDA for Sonopsy.

Pre-market Notification Details

• Device ID: K013109
• 510k Number: K013109
• Device Name: SONOPSY
• Classification: Biopsy Needle
• Applicant: HAKKO MEDICAL CO., LTD. 7-9 KAMIMEGURO 1-CHOME Meguro-ku, Tokyo, JP 153
• Contact: Shiro Jitagawa
• Correspondent: Shiro Jitagawa; HAKKO MEDICAL CO., LTD. 7-9 KAMIMEGURO 1-CHOME Meguro-ku, Tokyo, JP 153
• Product Code: FCG
• CFR Regulation Number: 876.1075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-09-17
• Decision Date: 2002-03-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
14526737120055	K013109	000
14526737120048	K013109	000