FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
PuraStat
K Number: K242250
·
Decision Oct 22, 2024
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
10
Applicant Total
4
Review Days
83
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Basic Information
- Device Name
- PuraStat
- K Number
- K242250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4456
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3-D Matrix Europe SAS
- Date Received
- July 31, 2024
- Decision Date
- October 22, 2024
- Product Code
- QAU
- 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 |
|---|---|---|---|
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | FDA class 2 | General, Plastic Surgery |
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