The Sex Gel— 510(k) K181078

Substantially Equivalent

Necessaire, Inc.

FDA 510(k) clearance K181078 for The Sex Gel, Substantially Equivalent on 2018-09-10. Applicant: Necessaire, Inc..

Clearance details

Applicant: Necessaire, Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2018-04-24
Decision date: 2018-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manhattan Beach, CA, 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.