LubriZenzs— 510(k) K242712

Substantially Equivalent

Sk Zen, LLC

FDA 510(k) clearance K242712 for LubriZenzs, Substantially Equivalent on 2025-06-04. Applicant: Sk Zen, LLC.

Clearance details

Applicant: Sk Zen, LLC
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2024-09-09
Decision date: 2025-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.