510(k) Report

FDA applicant

Professional Pharmacy West, Inc.

Charleston, SC1 decision1987–19870 recalls

FDA records 1 decision for Professional Pharmacy West, Inc. (Charleston, SC) in 1987: 1 510(k) clearance. All are in product code HIS (Condom). 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 Professional Pharmacy West, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Professional Pharmacy West, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Professional Pharmacy West, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Professional”

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