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Cook Urological, Inc.

United StatesFDA applicant, unverified

Devices
104
FDA recalls
6

What Cook Urological, Inc. makes

Cook Urological, Inc. manufactures urological and gynecological surgical instruments, including bipolar cutters, biopsy devices, and endoscopic tools like the Rutner biopsy device and Hasson 360 series grasping forceps. The company also produces pipettes for pre-implantation genetic diagnostics, urethral dilation instruments, and stents for urinary and uterine applications. Additional offerings include CO₂ pneumo-dissectors, fetal membrane manipulators, endosnares, and injection needles for medical procedures.

The portfolio includes devices classified as Class I, Class II, and Class U under regulatory frameworks, with submissions recorded in the FDA’s 510(k) clearance registry. Products are listed in the United States, where the manufacturer is based.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue104

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FDA recalls6

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

  • 2007

    • 12 Jun 2007 Z-1162-2007 Unclassified (pre-2012) Terminated Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed. Distribution: Nationwide and Canada.
    • 5 Jan 2007 Z-0377-2007 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the packages may not have been sealed. Distribution: Massachusetts, Maine, New Hampshire and Puerto Rico. Submission number: K043418

  • 2006

    • 1 Mar 2006 Z-0674-06 Unclassified (pre-2012) Terminated Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58. Distribution: Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New…
      Full distribution text Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela.

  • 2005

    • 1 Aug 2005 Z-1584-05 Unclassified (pre-2012) Terminated Mislabeled as to size. Distribution: California and Florida. Submission number: K811833

  • 2003

    • 22 Jan 2003 Z-0554-03 Unclassified (pre-2012) Terminated Product is labeled sterile, but was not sterilized. Distribution: Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland. Submission number: K990072
    • 22 Jan 2003 Z-0555-03 Unclassified (pre-2012) Terminated Product is labeled sterile, but was not sterilized. Distribution: Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland. Submission number: K990072