510(k) K240994
- Device
- Nexpowder
- Applicant
- Nextbiomedical Co., Ltd.
- 510(k) number
- K240994
- Product code
- QAU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-27
- Date received
- 2024-04-11
- Regulation
- 878.4456
- Classification name
- Hemostatic Device For Endoscopic Gastrointestinal Use
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kim Suji
- Address
- 6, Venture-Ro 100beon-Gil, Yeonsu-Gu Incheon KR 22013 22013
FDA Registration Numbers#
- 3002807408
- 1450662
- 3030733800
- 3004681519
- 3015528146
- 3005465238
- 3014579161
- 3007225047
- 1037905
- 3013557562
- 3013155768
- 3020614064
- 3012263097
- 1036836
- 1058584
- 3007162658
- 3005689226
Source Documents#
Other 510(k) Records For Product Code QAU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253924 | PuraStat | 3-D Matrix Europe SAS | 2026-01-07 |
| K242250 | PuraStat | 3-D Matrix Europe SAS | 2024-10-22 |
| K234131 | Resolv Endoscopic Hemostat System | Hemostasis, LLC | 2024-07-26 |
| K222481 | PuraStat | 3-D Matrix, Inc. | 2023-02-28 |
| K202929 | Nexpowder | Nextbiomedical Co., Ltd. | 2022-09-16 |
| K210098 | PuraStat-GI | 3-D Matrix, Inc. | 2021-06-25 |
| K190677 | EndoClot | Endoclot Plus Co., Ltd. | 2021-01-29 |
| K200972 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2020-06-10 |
| DEN170015 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2018-05-07 |