510(k) K260502
K260502 is an FDA 510(k) premarket notification submitted by HR Healthcare for the device "Liv Pre-lubricated Intermittent Catheter". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. HR Healthcare has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2026
- Date Received
- February 13, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type