Nexpowder
FDA 510(k) clearance K202929 · decided 2022-09-16
Clearance details
- K-number
- K202929
- Device name
- Nexpowder
- Applicant
- Nextbiomedical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-29
- Decision date
- 2022-09-16
- Days to decision
- 717 days
- Clearance type
- Traditional
- Product code
- QAU
- Device class
- 2
- Regulation number
- 878.4456
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Incheon, KR
- Third-party review
- No
- Expedited review
- No
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| Resolv Endoscopic Hemostat System (K234131) | Hemostasis, LLC | 2024-07-26 |
| PuraStat (K222481) | 3-D Matrix, Inc. | 2023-02-28 |
| PuraStat-GI (K210098) | 3-D Matrix, Inc. | 2021-06-25 |
| EndoClot (K190677) | Endoclot Plus Co., Ltd. | 2021-01-29 |
| Hemospray Endoscopic Hemostat (K200972) | Wilson-Cook Medical, Inc. | 2020-06-10 |
| Hemospray Endoscopic Hemostat (DEN170015) | Wilson-Cook Medical, Inc. | 2018-05-07 |
Recalls involving this device
No recalls on record reference this clearance.