FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ax-Surgi Surgical Hemostat
K Number: K213198
·
Decision Jan 5, 2023
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
5
Applicant Total
5
Review Days
463
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Basic Information
- Device Name
- Ax-Surgi Surgical Hemostat
- K Number
- K213198
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4454
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advamedica, Inc.
- Date Received
- September 29, 2021
- Decision Date
- January 5, 2023
- Product Code
- POD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| POD | Temporary, Internal Use Hemostatic | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Advamedica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K212766 | Maxiocel Chitosan Wound Dressing | Aug 24, 2023 | Substantially Equivalent |
| K222909 | Axiostat Gauze | Apr 7, 2023 | Substantially Equivalent |
| K202830 | Axiostat Patch | Apr 15, 2021 | Substantially Equivalent |
| K172324 | Axiostat Chitosan Hemostatic Dressing | Feb 23, 2018 | Substantially Equivalent |