Liv Pre-lubricated Intermittent Catheter— 510(k) K260502
Substantially EquivalentHR Healthcare
FDA 510(k) clearance K260502 for Liv Pre-lubricated Intermittent Catheter, Substantially Equivalent on 2026-03-12. Applicant: HR Healthcare. Device class: 2.
Summary
HR Healthcare's Liv Pre-lubricated Intermittent Catheter is filed under EZD, straight catheters. The record doesn't list catheter sizes.
Class II, 21 CFR 876.5130. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
HR Healthcare filed from York, Pennsylvania. The decision came 27 calendar days after receipt (February 13 to March 12, 2026). The record flags it as a third-party review.
Clearance details
- Applicant
- HR Healthcare
- Product code
- Product code EZD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
Recent devices under product code EZD
view allMore clearances from HR Healthcare
view allAdverse events under product code EZD
product code EZD- Injury
- 864
- Malfunction
- 2,210
- Total
- 3,074
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.