FDA applicant

Concept, Inc.

Mchenry, IL84 decisions1976–19920 recalls

FDA records 84 decisions for Concept, Inc. (Mchenry, IL) from 1976 to 1992: 83 510(k) clearances and 1 original PMA approval. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HRX (Arthroscope). 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 Concept, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Concept, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Concept”

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

Concept Rubber Products Sdn Bhd 2

Concept, 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 “Concept”