K-Y BRAND ULTRA GEL PERSONAL LUBRICANT— 510(k) K020827

Substantially Equivalent

Personal Products Co., Div. of Mcneil Ppc, Inc.

FDA 510(k) clearance K020827 for K-Y BRAND ULTRA GEL PERSONAL LUBRICANT, Substantially Equivalent on 2002-06-12. Applicant: Personal Products Co., Div. of Mcneil Ppc, Inc..

Clearance details

Applicant: Personal Products Co., Div. of Mcneil Ppc, Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2002-03-14
Decision date: 2002-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skillman, 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.