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

Name: FDA 510(k) clearance K003867
Creator: U.S. Food and Drug Administration
Published: 2001-03-09

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.. Device class: 2.

Clearance details

Applicant: Biofilm, Inc.
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
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 ↗

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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.