FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QuikClot Control+ Hemostatic Device
K Number: K243553
·
Decision Mar 18, 2025
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
5
Applicant Total
39
Review Days
120
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Basic Information
- Device Name
- QuikClot Control+ Hemostatic Device
- K Number
- K243553
- 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
- Teleflex Medical
- Date Received
- November 18, 2024
- Decision Date
- March 18, 2025
- 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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