510(k) K262045
K262045 is an FDA 510(k) premarket notification submitted by Coloplast A.S. for the device "Luja Soft". The FDA issued a decision of Substantially Equivalent on July 7, 2026. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2026
- Date Received
- June 17, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type