510(k) Report

FDA applicant

Thomas Surgical Instruments, Inc.

Traverse City, MI1 decision2009–20090 recalls

FDA records 1 decision for Thomas Surgical Instruments, Inc. (Traverse City, MI) in 2009: 1 510(k) clearance. All are in product code FST (Light, Surgical, Fiberoptic). 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 Thomas Surgical Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Thomas Surgical Instruments, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Thomas Surgical Instruments, Inc.’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 “Thomas”

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