FDA applicant

Site Microsurgical Systems, Inc.

Horsham, PA30 decisions1986–19940 recalls

FDA records 30 decisions for Site Microsurgical Systems, Inc. (Horsham, PA) from 1986 to 1994: 30 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and HQE (Instrument, Vitreous Aspiration And Cutting…). 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 Site Microsurgical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Site Microsurgical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Site Microsurgical Systems, 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

Other applicant names beginning “Site”

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

Site Saver, Inc. D/B/A Lineus Medical 1

Site Microsurgical Systems, 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?

Other applicant names beginning “Site”