JO Classic Hybrid Personal Lubricant— 510(k) K181408

Substantially Equivalent

United Consortium

FDA 510(k) clearance K181408 for JO Classic Hybrid Personal Lubricant, Substantially Equivalent on 2018-08-27. Applicant: United Consortium.

Clearance details

Applicant: United Consortium
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2018-05-30
Decision date: 2018-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, 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.