FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid
K Number: K253791
·
Decision Feb 26, 2026
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
279
Applicant Total
2
Review Days
90
Basic Information
- Device Name
- PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid
- K Number
- K253791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DePuy Mitek, Inc.
- Date Received
- November 28, 2025
- Decision Date
- February 26, 2026
- Product Code
- KCT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
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Other Clearances by DePuy Mitek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233675 | FMS VUE Fluid Management and Tissue Debridement System | Feb 26, 2024 | Substantially Equivalent |