510(k) Report

510(k) · Cleared

Cleared

Wilson-Cook Esophageal Prosthesis

K896390510(k) TraditionalCleared Dec 27, 198951-day reviewClass II21 CFR 878.3610

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wilson-Cook Medical, Inc. · JCQ Prosthesis, Esophagus

Cleared on Dec 27, 1989 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 27, 1989
Review
51 days
Class
Class II
Product code
JCQ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K896390Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JCQ devices

JCQ Prosthesis, Esophagus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JCQ

FDA has decided no JCQ device since 2007.

Median 510(k) review, days · JCQ

Too few JCQ 510(k)s in any year since 2007 to give a median.

Recalls per year · JCQ

No recall names JCQ since 2007.

Adverse event reports per year · JCQ

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code JCQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
20260—0—

More from Wilson-Cook Medical, Inc.

125 FDA decisions under this applicant name. See the company

  • K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 20261 recall
  • K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 20251 recall
  • K213356Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
  • K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 20211 recall
  • K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020

https://510kreport.com/device/K896390 · printed Nov 6, 2026

Cite this page

510(k) Report. “K896390: Wilson-Cook Esophageal Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896390

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026