FDA applicant

Cook Biotech Incorprated

West Lafayette, IN4 decisions2013–20150 recalls

FDA records 4 decisions for Cook Biotech Incorprated (West Lafayette, IN) from 2013 to 2015: 4 510(k) clearances. Most are in product codes KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil…) and FTM (Mesh, Surgical). Its devices cite 6 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, ear, nose and throat panel, where it files most

How often FDA has decided Cook Biotech Incorprated’s devices, and how often a recall has named them.

FDA decisions per year

3in 2015

2013high 3 (2015) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

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

Planning a device like Cook Biotech Incorprated’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 Endoscopy 5 Cook Medical Incorporated 3 Cook (Canada), Inc. 1 Cook Advanced Technologies 1 Cook Corporated 1

Cook Biotech Incorprated

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”