Hemospray Endoscopic Hemostat
FDA 510(k) clearance DEN170015 · decided 2018-05-07
Clearance details
- K-number
- DEN170015
- Device name
- Hemospray Endoscopic Hemostat
- Applicant
- Wilson-Cook Medical, Inc.
- Decision
- Unknown
- Date received
- 2017-03-09
- Decision date
- 2018-05-07
- Days to decision
- 424 days
- Clearance type
- Direct
- Product code
- QAU
- Device class
- 2
- Regulation number
- 878.4456
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Winston-Salem, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PuraStat GI (K261503) | 3-D Matrix, Inc. | 2026-08-03 |
| Hemospray Endoscopic Hemostat (HEMO-[X]) (K253302) | Wilson-Cook Medical, Inc. | 2026-06-02 |
| PuraStat (K253924) | 3-D Matrix Europe SAS | 2026-01-07 |
| Nexpowder (K240994) | Nextbiomedical Co., Ltd. | 2024-11-27 |
| PuraStat (K242250) | 3-D Matrix Europe SAS | 2024-10-22 |
| Resolv Endoscopic Hemostat System (K234131) | Hemostasis, LLC | 2024-07-26 |
| PuraStat (K222481) | 3-D Matrix, Inc. | 2023-02-28 |
| Nexpowder (K202929) | Nextbiomedical Co., Ltd. | 2022-09-16 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.