Sage 2-in-1 Personal Lubricant and Moisturizer— 510(k) K190150

Substantially Equivalent

Fairhaven Health, LLC

FDA 510(k) clearance K190150 for Sage 2-in-1 Personal Lubricant and Moisturizer, Substantially Equivalent on 2019-07-16. Applicant: Fairhaven Health, LLC.

Clearance details

Applicant: Fairhaven Health, LLC
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2019-01-30
Decision date: 2019-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellingham, WA, 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.