510(k) DEN170015
- Device
- Hemospray Endoscopic Hemostat
- Applicant
- Wilson-Cook Medical, Inc.
- 510(k) number
- DEN170015
- Product code
- QAU
- Decision
- Unknown (DENG)
- Decision date
- 2018-05-07
- Date received
- 2017-03-09
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Marge Walls-Walker
- Address
- 4900 Bethania Station Rd. Winston-Salem NC US 27105 27105
FDA Registration Numbers#
- 3002807408
- 1450662
- 3030733800
- 3004681519
- 3015528146
- 3005465238
- 3014579161
- 3007225047
- 1037905
- 3013557562
- 3013155768
- 3020614064
- 3012263097
- 1036836
- 1058584
- 3007162658
- 3005689226
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QAU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253924 | PuraStat | 3-D Matrix Europe SAS | 2026-01-07 |
| K240994 | Nexpowder | Nextbiomedical Co., Ltd. | 2024-11-27 |
| 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 |