Ah!Yes Ob Coco Personal Lubricant— 510(k) K191411

Substantially Equivalent

Bio-Tech Lubricants, Ltd.

FDA 510(k) clearance K191411 for Ah!Yes Ob Coco Personal Lubricant, Substantially Equivalent on 2020-02-06. Applicant: Bio-Tech Lubricants, Ltd..

Clearance details

Applicant: Bio-Tech Lubricants, Ltd.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2019-05-28
Decision date: 2020-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southampton, 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.