510(k) Report

FDA applicant

Gesco Intl., Inc.

San Antonio, TX26 decisions1978–19950 recalls

FDA records 26 decisions for Gesco Intl., Inc. (San Antonio, TX) from 1978 to 1995: 26 510(k) clearances. Most are in product codes FOS (Catheter, Umbilical Artery) and LJS (Catheter, Intravascular, Therapeutic…). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Gesco Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report