REPHRESH VAGINAL GEL— 510(k) K021737

Substantially Equivalent

Columbia Laboratories, Inc.

FDA 510(k) clearance K021737 for REPHRESH VAGINAL GEL, Substantially Equivalent on 2002-08-26. Applicant: Columbia Laboratories, Inc..

Clearance details

Applicant: Columbia Laboratories, Inc.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2002-05-28
Decision date: 2002-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville Centre, NY, US

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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.