Ax-Surgi Surgical Hemostat
FDA 510(k) clearance K213198 · decided 2023-01-05
Clearance details
- K-number
- K213198
- Device name
- Ax-Surgi Surgical Hemostat
- Applicant
- Advamedica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-29
- Decision date
- 2023-01-05
- Days to decision
- 463 days
- Clearance type
- Traditional
- Product code
- POD
- Device class
- 2
- Regulation number
- 878.4454
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Cambridge, MA, 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 |
|---|---|---|
| QuikClot Control+ Hemostatic Device (K243553) | Teleflex Medical | 2025-03-18 |
| QuikClot Control+ Hemostatic Dressing (K220971) | Z-Medica, LLC | 2022-12-14 |
| QuikClot Control+ (K200167) | Z-Medica, LLC | 2020-04-23 |
| NuStat (K183190) | Beeken Biomedical, LLC | 2019-09-25 |
| D2 Dressing (DEN160012) | Z-Medica, LLC | 2017-06-30 |
Recalls involving this device
No recalls on record reference this clearance.