510(k) Report

FDA applicant

Principle & Will Co., Ltd.

Apia, WS1 decision2026–20260 recalls

FDA records 1 decision for Principle & Will Co., Ltd. (Apia, WS) in 2026: 1 510(k) clearance. All are in product code FYA (Gown, Surgical). 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 Principle & Will Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

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Other applicant names beginning “Principle”

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