FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
Disposable Percutaneous Nephrostomy Dilatation Kit
K Number: K250448
·
Decision Jul 3, 2025
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
55
Applicant Total
3
Review Days
135
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Basic Information
- Device Name
- Disposable Percutaneous Nephrostomy Dilatation Kit
- K Number
- K250448
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Trious Medical Technology Co., Ltd.
- Date Received
- February 18, 2025
- Decision Date
- July 3, 2025
- Product Code
- LJE
- 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 |
|---|---|---|---|
| LJE | Catheter, Nephrostomy | FDA unclassified | Unknown |
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