FDA applicant

Andersen Products, Inc.

Haw River, NC2 decisions2001–20020 recalls

FDA records 2 decisions for Andersen Products, Inc. (Haw River, NC) from 2001 to 2002: 2 510(k) clearances. All are in product code KNT (Tubes, Gastrointestinal (And Accessories)). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, gastroenterology and urology panel, where it files most

How often FDA has decided Andersen Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Andersen Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Andersen Products, 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 “Andersen”

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

Andersen Sterilizers, Inc. 19

Andersen Products, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Andersen”