FDA applicant

Cook Endoscopy

Winston-Salem, NC5 decisions2003–20200 recalls

FDA records 5 decisions for Cook Endoscopy (Winston-Salem, NC) from 2003 to 2020: 4 510(k) clearances and 1 original PMA approval. Most are in product codes KNQ (Dilator, Esophageal) and PKL (Hemostatic Metal Clip For The Gi Tract). Its devices cite 8 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 Cook Endoscopy’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cook Endoscopy’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 “Cook”

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

Cook, Inc. 371 Cook Urological, Inc. 104 Cook Biotech, Inc. 47 Cook Ob/Gyn 43 Cook Ireland, Ltd. 37 Cook Pacemaker Corp. 35 Cook Vascular, Inc. 12 Cook Biotech Incorprated 4 Cook Medical Incorporated 3 Cook (Canada), Inc. 1 Cook Advanced Technologies 1 Cook Corporated 1

Cook Endoscopy

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 “Cook”