K-Y BRAND WARMING JELLY PERSONAL LUBRICANT— 510(k) K040164

Substantially Equivalent

Personal Products Company, Div. of Mcneil-Ppc, Inc.

FDA 510(k) clearance K040164 for K-Y BRAND WARMING JELLY PERSONAL LUBRICANT, Substantially Equivalent on 2004-04-05. Applicant: Personal Products Company, Div. of Mcneil-Ppc, Inc..

Clearance details

Applicant: Personal Products Company, Div. of Mcneil-Ppc, Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2004-01-26
Decision date: 2004-04-05
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.