510(k) Report

FDA applicant

Instent, Inc.

Eden Prairie, MN4 decisions1995–19960 recalls

FDA records 4 decisions for Instent, Inc. (Eden Prairie, MN) from 1995 to 1996: 4 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and ESW (Prosthesis, Esophageal). 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 Instent, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Instent, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Instent, Inc.’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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Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts2decisions
  • ESWProsthesis, Esophageal2decisions

Who builds on its devices?

Later devices cite its devices 4 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.

  • K955041Instent Esophacoil Self-Expanding Stent SystemInstent, Inc. · 19962cite it
  • K941487Instent Esophacoil Esophageal ProsthesisInstent, Inc. · 19952cite it

What has FDA decided for it lately?

  • K955041Instent Esophacoil Self-Expanding Stent SystemInstent, Inc. · 1996
  • K945498Instent Endocoil-T (TM) Transhepatic Biliary EndoprosthesisInstent, Inc. · 1995
  • K924387Instent Endocoil Biliary EndoprosthesisInstent, Inc. · 1995
  • K941487Instent Esophacoil Esophageal ProsthesisInstent, Inc. · 1995

All 4 as Instent, Inc. →