FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
K Number: K241734
·
Decision Mar 5, 2025
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
70
Applicant Total
3
Review Days
261
Basic Information
- Device Name
- Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
- K Number
- K241734
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Well Lead Medical Co., Ltd.
- Date Received
- June 17, 2024
- Decision Date
- March 5, 2025
- Product Code
- GBM
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GBM | Catheter, Urethral | FDA class 2 | Gastroenterology, Urology |
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