510(k) K221328— Bloomi Smooth Water Based Lubricant

Substantially Equivalent

The Bloomi Inc..

Clearance details

Applicant: The Bloomi Inc..
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2022-05-06
Decision date: 2022-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alamo, CA, US

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.