ONE PERSONAL LUBRICANT (WATER BASED)— 510(k) K110691

Name: FDA 510(k) clearance K110691
Creator: U.S. Food and Drug Administration
Published: 2012-02-01

Substantially Equivalent

One

FDA 510(k) clearance K110691 for ONE PERSONAL LUBRICANT (WATER BASED), Substantially Equivalent on 2012-02-01. Applicant: One. Device class: 2.

Clearance details

Applicant: One
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2011-03-11
Decision date: 2012-02-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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K110690 — ONE PERSONAL LUBRICANT (SILICONE)2012-03-28

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.