FDA applicant

Apogee Medical, Inc.

Youngsville, NC2 decisions2001–20040 recalls

FDA records 2 decisions for Apogee Medical, Inc. (Youngsville, NC) from 2001 to 2004: 2 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and GBM (Catheter, Urethral). Its devices cite 2 predicates, 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Apogee Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Apogee 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 “Apogee”

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

Apogee, Inc. 2 Apogee Orthosolutions 1 Apogee Medical Products, Inc. 1

Apogee 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 “Apogee”