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 |
Trademark Results [SONOPSY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONOPSY 75187973 2219424 Dead/Cancelled |
NeoVision Corporation 1996-10-28 |
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