FDA 510(k)
FDA unclassified
Substantially Equivalent
🇫🇷 France
PuraStat
K Number: K242634
·
Decision Jan 15, 2025
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
3
Applicant Total
4
Review Days
134
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Basic Information
- Device Name
- PuraStat
- K Number
- K242634
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3-D Matrix Europe SAS
- Date Received
- September 3, 2024
- Decision Date
- January 15, 2025
- Product Code
- PHN
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| PHN | Protective Coating, Mucoadhesive Application, For The Rectal Mucosa | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PHN), ordered by most recent decision date.
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