Nexpowder
Hemostatic Device For Endoscopic Gastrointestinal Use
Nextbiomedical Co., Ltd.
The following data is part of a premarket notification filed by Nextbiomedical Co., Ltd. with the FDA for Nexpowder.
Pre-market Notification Details
| Device ID | K202929 |
| 510k Number | K202929 |
| Device Name: | Nexpowder |
| Classification | Hemostatic Device For Endoscopic Gastrointestinal Use |
| Applicant | Nextbiomedical Co., Ltd. 6 Venture-ro 100 Beon-gil, Yeonsu-gu Incheon, KR 22013 |
| Contact | Jin Young Lee |
| Correspondent | Kyungyoon Kang K-Bio Solutions 201 South 4th St, Suite 727 San Jose, CA 95112 |
| Product Code | QAU |
| CFR Regulation Number | 878.4456 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2022-09-16 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18800038405186 | K202929 | 000 |
| 08800038405332 | K202929 | 000 |
Trademark Results [Nexpowder]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEXPOWDER 79295194 not registered Live/Pending |
NEXTBIOMEDICAL CO., LTD. 2020-08-27 |
 NEXPOWDER 79283530 not registered Live/Pending |
NEXTBIOMEDICAL CO., LTD. 2020-03-18 |
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