FDA applicant

Intersect Ent.

Menlo Park2 decisions2011–20220 recalls

FDA records 2 decisions for Intersect Ent. (Menlo Park) from 2011 to 2022: 1 510(k) clearance and 1 original PMA approval. Most are in product codes OWO (Drug-Eluting Sinus Stent) and LRC (Instrument, Ent Manual Surgical). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2022

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Intersect Ent. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intersect Ent.’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 “Intersect”

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

Intersect Systems, Inc. 21 Intersect Medical Products, Inc. 5

Intersect Ent.

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 “Intersect”