FDA applicant

Surgilite Intl., Inc.

Mchenry, IL5 decisions1977–19830 recalls

FDA records 5 decisions for Surgilite Intl., Inc. (Mchenry, IL) from 1977 to 1983: 5 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FRG (Wrap, Sterilization). 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 Surgilite Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgilite Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Surgilite Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?