YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer— 510(k) K162569

Substantially Equivalent

Biotech Lubricants, Ltd.

FDA 510(k) clearance K162569 for YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer, Substantially Equivalent on 2017-06-09. Applicant: Biotech Lubricants, Ltd..

Clearance details

Applicant: Biotech Lubricants, Ltd.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2016-09-15
Decision date: 2017-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petersfield, GB

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.