510(k) Report

FDA applicant

United Surgical Corp.

Irvine, CA7 decisions1983–19900 recalls

FDA records 7 decisions for United Surgical Corp. (Irvine, CA) from 1983 to 1990: 7 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and GAG (Stapler, Surgical). 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, ophthalmic panel, where it files most

How often FDA has decided United Surgical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for United Surgical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like United Surgical Corp.’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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