510(k) Report

FDA applicant

Aplan Well Enterprise Co., Ltd.

Hsin Chu City, TW1 decision2012–20120 recalls

FDA records 1 decision for Aplan Well Enterprise Co., Ltd. (Hsin Chu City, TW) in 2012: 1 510(k) clearance. All are in product code FIE (Needle, Fistula). 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 Aplan Well Enterprise Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Aplan Well Enterprise Co., Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FIENeedle, Fistula1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K112734Aplan a.V. Fistula Needle SetAplan Well Enterprise Co., Ltd. · 2012

The one decision as Aplan Well Enterprise Co., Ltd. →