510(k) K241734
K241734 is an FDA 510(k) premarket notification submitted by Well Lead Medical Co., Ltd. for the device "Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact". The FDA issued a decision of Substantially Equivalent on March 5, 2025. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. Well Lead Medical Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2025
- Date Received
- June 17, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urethral
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type