TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)— 510(k) K180764

Substantially Equivalent

Church & Dwight Co., Inc.

FDA 510(k) clearance K180764 for TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant), Substantially Equivalent on 2018-08-01. Applicant: Church & Dwight Co., Inc..

Clearance details

Applicant: Church & Dwight Co., Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2018-03-23
Decision date: 2018-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ewing, NJ, 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.