FDA applicant

Hedgepath, LLC

Tampa, FL1 decision2013–20130 recalls

FDA records 1 decision for Hedgepath, LLC (Tampa, FL) in 2013: 1 510(k) clearance. All are in product code KAR (Irrigator, Sinus). 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, ear, nose and throat panel, where it files most

How often FDA has decided Hedgepath, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Hedgepath, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Hedgepath, LLC

Which product codes does it file in?

What has FDA decided for it lately?