Mano and Mano Personal Lubricant— 510(k) K161585

Substantially Equivalent

Mano and Mano Proprietary Limited

FDA 510(k) clearance K161585 for Mano and Mano Personal Lubricant, Substantially Equivalent on 2016-09-06. Applicant: Mano and Mano Proprietary Limited.

Clearance details

Applicant: Mano and Mano Proprietary Limited
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2016-06-08
Decision date: 2016-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moorabbin, AU

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.