Cook Urological, Inc.
United StatesFDA applicant, unverified
- Devices
- 104
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
Search and filter all 104 devicesShowing 1-50 of 104
FDA recalls
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.
- 5 Jan 2007 Z-0377-2007 Unclassified (pre-2012) Terminated Lack of assurance of sterility, as the packages may not have been sealed.
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.
Full distribution text
- 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.
2005
- 1 Aug 2005 Z-1584-05 Unclassified (pre-2012) Terminated Mislabeled as to size.
2003
- 22 Jan 2003 Z-0554-03 Unclassified (pre-2012) Terminated Product is labeled sterile, but was not sterilized.
- 22 Jan 2003 Z-0555-03 Unclassified (pre-2012) Terminated Product is labeled sterile, but was not sterilized.
Frequently asked questions
How many devices does Cook Urological, Inc. have in the registry?
The registry currently lists 104 devices for Cook Urological, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cook Urological, Inc.'s devices?
Among its 50 most recently registered devices, Cook Urological, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Cook Urological, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Cook Urological, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cook Urological, Inc.?
FDA recall records list 6 recalls initiated by Cook Urological, Inc., the most recent initiated on 2007-06-12. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cook Urological, Inc. in the registry?
The most recently registered devices listed for Cook Urological, Inc. include 3 WAY SILICONE FOLEY BALLOON CATHETER, AQ HYDROPHILIC DILATORS, BIPOLAR CUTTER and RUTNER BIOPSY DEVICE.