510(k) Report

FDA applicant

Exitec, Inc.

Mchenry, IL4 decisions1982–19830 recalls

FDA records 4 decisions for Exitec, Inc. (Mchenry, IL) from 1982 to 1983: 4 510(k) clearances. Most are in product codes HIB (Speculum, Vaginal, Nonmetal) and KNT (Tubes, Gastrointestinal (And Accessories)). 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 Exitec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Exitec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Exitec, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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