510(k) Report

FDA applicant

Wilson-Cook Medical Inc./Cook Endoscopy

Winston-Salem, NC7 decisions2012–20190 recalls

FDA records 7 decisions for Wilson-Cook Medical Inc./Cook Endoscopy (Winston-Salem, NC) from 2012 to 2019: 7 510(k) clearances. Most are in product codes KNS (Unit, Electrosurgical, Endoscopic (With Or…) and NEU (Marker, Radiographic, Implantable). Since 2016 its 510(k)s took a median of 260 days from receipt to decision, against 62 for FDA’s reviews in the same codes and years. 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 Wilson-Cook Medical Inc./Cook Endoscopy’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2012: 22017: 22018: 22019: 1
2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Wilson-Cook Medical Inc./Cook Endoscopy by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)3decisions
  • NEUMarker, Radiographic, Implantable1decision
  • FDXEndoscopic Cytology Brush1decision
  • FBKEndoscopic Injection Needle, Gastroenterology-Urology1decision
  • PKLHemostatic Metal Clip For The Gi Tract1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 260 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 62 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K111895Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 20123cite it
  • K172288Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy · 20182cite it
  • K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS®…Wilson-Cook Medical Inc./Cook Endoscopy · 20182cite it
  • K121505Disposable Hemostasis ChipWilson-Cook Medical Inc./Cook Endoscopy · 20121cites it
  • K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy · 20171cites it

What has FDA decided for it lately?

  • K190829Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)Wilson-Cook Medical Inc./Cook Endoscopy · 2019
  • K172665Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS®…Wilson-Cook Medical Inc./Cook Endoscopy · 2018
  • K172288Fusion OMNI SphincterotomeWilson-Cook Medical Inc./Cook Endoscopy · 2018
  • K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy · 2017
  • K171607Bronchi and Gastrointestinal Cytology BrushWilson-Cook Medical Inc./Cook Endoscopy · 2017
  • K121505Disposable Hemostasis ChipWilson-Cook Medical Inc./Cook Endoscopy · 2012
  • K111895Echotip (R) Ultra Fiducial NeedleWilson-Cook Medical Inc./Cook Endoscopy · 2012

All 7 as Wilson-Cook Medical Inc./Cook Endoscopy →

Other applicant names beginning “Wilson-Cook”

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

Wilson-Cook Medical, Inc. 127Wilson Greatbatch Technologies, Inc. 9Wilson Glove Products Co., Ltd. 2Wilson Biomedical, Inc. 2Wilson Instruments (Shanghai) Company Limited 2Wilson Hunt Intl./, Ltd. 1Wilson Tech (International) Limited 1Wilson Instruments (Sha) Co., Ltd. 1Wilson Medical Instruments Co. 1