510(k) Report

FDA applicant

Columbia Laboratories, Inc.

Rockville Centre, NY1 decision2002–20020 recalls

FDA records 1 decision for Columbia Laboratories, Inc. (Rockville Centre, NY) in 2002: 1 510(k) clearance. All are in product code NUC (Lubricant, Personal). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Columbia Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Columbia Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Columbia Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NUCLubricant, Personal1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K021737Rephresh Vaginal GelColumbia Laboratories, Inc. · 20021cites it

What has FDA decided for it lately?

  • K021737Rephresh Vaginal GelColumbia Laboratories, Inc. · 2002

The one decision as Columbia Laboratories, Inc. →

Other applicant names beginning “Columbia”

FDA records each applicant name separately; these may or may not be the same firm.

Columbia Bioscience, Inc. 13Columbia Scientific, Inc. 7Columbia Medical & Surgical, Inc. 4Columbia Diagnostics, Inc. 2Columbia Scientific Development, LLC 1Columbia Medical Manufacturing, LLC 1Columbia Medical Mfg, LLC 1