FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Axiostat Chitosan Hemostatic Dressing
K Number: K172324
·
Decision Feb 23, 2018
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
115
Applicant Total
5
Review Days
206
Basic Information
- Device Name
- Axiostat Chitosan Hemostatic Dressing
- K Number
- K172324
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advamedica Inc.
- Date Received
- August 1, 2017
- Decision Date
- February 23, 2018
- Product Code
- QSY
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | FDA unclassified | Unknown |
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