510(k) Report

FDA applicant

Ocular Systems, Inc.

Winston-Salem, NC1 decision2011–20110 recalls

FDA records 1 decision for Ocular Systems, Inc. (Winston-Salem, NC) in 2011: 1 510(k) clearance. All are in product code OTZ (Graft Insertion Instrument For Endothelial…). 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 Ocular Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Ocular Systems, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OTZGraft Insertion Instrument For Endothelial Keratoplasty1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K090626EndoserterOcular Systems, Inc. · 20112cite it

What has FDA decided for it lately?

  • K090626EndoserterOcular Systems, Inc. · 2011

The one decision as Ocular Systems, Inc. →

Other applicant names beginning “Ocular”

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

Ocular Instruments, Inc. 50Ocular Sciences Puerto Rico, Inc. 7Ocular Therapeutix, Inc. 2Ocular Sciences 2Ocular Innovations, Inc. 2Ocular Blood Flow Laboratories, Inc. 2Ocular Concepts, LLC 1Ocular Pharmaceuticals, Inc. 1