FDA applicant

Angiosystems, Inc.

Great Neck, NY14 decisions1984–19910 recalls

FDA records 14 decisions for Angiosystems, Inc. (Great Neck, NY) from 1984 to 1991: 14 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and EKS (File, Pulp Canal, Endodontic). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Angiosystems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Angiosystems, 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

Angiosystems, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?