510(k) K213198
- Device
- Ax-Surgi Surgical Hemostat
- Applicant
- Advamedica, Inc.
- 510(k) number
- K213198
- Product code
- POD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-05
- Date received
- 2021-09-29
- Regulation
- 878.4454
- Classification name
- Temporary, Internal Use Hemostatic
- 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
- Leo Mavely
- Address
- Harvard Sq. 1, Mifflin Pl., Suite 400 Cambridge MA US 02138 02138
FDA Registration Numbers#
- 1219313
- 3009348684
- 3003898360
- 3015437221
- 3017391151
- 1220477
- 2245304
- 3015205402
- 3009600453
- 3015525200
- 3004138549
- 3011137372
- 1047843
- 3007829657
- 9680271
Source Documents#
Other 510(k) Records For Product Code POD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | 2025-03-18 |
| K220971 | QuikClot Control+ Hemostatic Dressing | Z-Medica, LLC | 2022-12-14 |
| K200167 | QuikClot Control+ | Z-Medica, LLC | 2020-04-23 |
| K183190 | NuStat | Beeken Biomedical, LLC | 2019-09-25 |
| DEN160012 | D2 Dressing | Z-Medica, LLC | 2017-06-30 |