510(k) Report

FDA applicant

Iris Surgical, LLC

St.Augustine, FL1 decision2001–20010 recalls

FDA records 1 decision for Iris Surgical, LLC (St.Augustine, FL) in 2001: 1 510(k) clearance. All are in product code HFX (Clamp, Circumcision). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Iris Surgical, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • HFXClamp, Circumcision1decision

What has FDA decided for it lately?

  • K010867Kilejian CircumcisorIris Surgical, LLC · 2001

The one decision as Iris Surgical, LLC →

Other applicant names beginning “Iris”

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

Iris International, Inc. 3Iris Diagnostics 2Iris 1Iris International Inc., A Division of Iris Iris I 1Iris USA 1Iris Optical, Inc. 1Iris Remote Imaging Systems 1Iris Molecular Diagnostics 1Iris Medical Ent., Inc. 1Iris Diagnostics, A Division of Iris International, Inc. 1