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Endochoice, Inc.

Country not established

Devices
111
FDA recalls
1

What Endochoice, Inc. makes

Endochoice, Inc. manufactures endoscopic devices for biliary, tracheal/bronchial, and esophageal procedures, including self-expanding metal stents (BONASTENT series), endoscopic ligators (AUTOBAND), irrigation systems (water bottle caps), and single-use valves (SmartStart, Seal). The portfolio also includes endoscopic forceps, a gastroscopy system (Fuse), and a processor-based endoscopic suite (Fuse Endoscopic System with FuseBox).

The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue111

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  • Fuse Colonoscopy System Ref K141598

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Injection Needle Ref K132065

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Seal Biopsy Valve - Reusable Ref K132776

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • rescuenet Ref K152580

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Peerscope System Ref K131422

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EndoChoice Select Injection Needle Ref K151475

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endochoice Hot Biopsy Forceps Ref K131991

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Biopsy Valve Ref K111821

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Endochoice Water Bottle Cap System Ref K142155

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Seal Single-Use Biopsy Valve Ref K133734

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fuse 1C Colonoscopy System Ref K132839

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 101-111 of 111

Showing 101-111 of 111

Company details

DUNS number
014154279
Phone
888-632-3636

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Endochoice, Inc., initiated on 2015-12-18. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2015

    • 18 Dec 2015 Z-0694-2016 Class II Terminated The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma. Distribution: Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia,…
      Full distribution text Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.
      Submission number: K141598