510(k) Report

FDA applicant

Hutchison Intl., Inc.

Bethesda, MD1 decision1999–19990 recalls

FDA records 1 decision for Hutchison Intl., Inc. (Bethesda, MD) in 1999: 1 510(k) clearance. All are in product code LCJ (Tissue Expander And Accessories). No recall is linked to its devices.

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

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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