FDA applicant

Key Surgical, Inc.

Minneapolis, MN6 decisions1989–20150 recalls

FDA records 6 decisions for Key Surgical, Inc. (Minneapolis, MN) from 1989 to 2015: 6 510(k) clearances. Most are in product codes MAW (Marker, Suture Identification) and GEI (Electrosurgical, Cutting & Coagulation &…). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

2in 2015

2007high 2 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Key Surgical, Inc.

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?