K200114

Substantially Equivalent

Astroglide Organix Liquid

Applicant: Biofilm, Inc.
Product code: NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2020-01-21
Decision date: 2020-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, 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.