Vaginal Moisturizing Gel— 510(k) K150615

Substantially Equivalent

Combe Incorporated

FDA 510(k) clearance K150615 for Vaginal Moisturizing Gel, Substantially Equivalent on 2015-05-01. Applicant: Combe Incorporated.

Clearance details

Applicant: Combe Incorporated
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2015-03-10
Decision date: 2015-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plains, NY, 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.