FDA applicant

Hakko Medical Co., Ltd.

Meguro-Ku, Tokyo, JP3 decisions2002–20030 recalls

FDA records 3 decisions for Hakko Medical Co., Ltd. (Meguro-Ku, Tokyo, JP) from 2002 to 2003: 3 510(k) clearances. Most are in product codes FCG (Biopsy Needle) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 8 predicates, 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 Hakko Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hakko Medical Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hakko Medical Co., Ltd.’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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Other applicant names beginning “Hakko”

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

Hakko Shoji Co., Ltd. 3

Hakko Medical Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Hakko”