DUREX EMBRACE PERSONAL LUBRICANT— 510(k) K140193

Substantially Equivalent

Reckitt Benckiser, LLC

FDA 510(k) clearance K140193 for DUREX EMBRACE PERSONAL LUBRICANT, Substantially Equivalent on 2014-11-04. Applicant: Reckitt Benckiser, LLC.

Clearance details

Applicant: Reckitt Benckiser, LLC
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2014-01-27
Decision date: 2014-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, 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.