FDA applicant

Entellus Medical, Inc.

Plymouth, MN27 decisions2008–20220 recalls

FDA records 27 decisions for Entellus Medical, Inc. (Plymouth, MN) from 2008 to 2022: 27 510(k) clearances. Most are in product codes LRC (Instrument, Ent Manual Surgical) and EOB (Nasopharyngoscope (Flexible Or Rigid)). Its devices cite 37 predicates, 22 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2022

2008high 6 (2011) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Entellus Medical, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Entellus Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Entellus”

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

Entellus Medical, Inc. (Aka Stryker Ent) 1

Entellus Medical, 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?

Other applicant names beginning “Entellus”