EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)— 510(k) K003867

Substantially Equivalent

Biofilm, Inc.

FDA 510(k) clearance K003867 for EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET), Substantially Equivalent on 2001-03-09. Applicant: Biofilm, Inc..

Clearance details

Applicant: Biofilm, Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2000-12-12
Decision date: 2001-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, 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.