Cook Ob/Gyn
Country not established
- Devices
- 43
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Cook Ob/Gyn makes
Cook Ob/Gyn manufactures diagnostic and therapeutic devices for gynecological and reproductive medicine, including tubal lumen support systems, hysteroscopy catheters (e.g., Sholkhoff and balloon dilation types), postpartum balloon catheters, laparoscopic catheters, and percutaneous suprapubic drainage sets. The company also provides specialized pipettes for assisted reproductive technologies, such as intracytoplasmic sperm injection (ICSI) and oocyte handling, alongside media buffers for in vitro fertilization (IVF) processes. Additional offerings include devices for female continence and intrauterine transfer sets for reproductive procedures.
The company’s products are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. These devices are listed in the FDA’s 510(k) registry, reflecting their regulatory status in the United States. The manufacturer operates from its U.S. headquarters.
Catalogue
Search and filter all 43 devicesFDA recalls
FDA recall records list 1 recall initiated by Cook Ob/Gyn, initiated on 2009-04-02. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 2 Apr 2009 Z-1416-2009 Unclassified (pre-2012) Terminated There is an ink on the brush which has not been tested for use with the Tao Brush.
Frequently asked questions
How many devices does Cook Ob/Gyn have in the registry?
The registry currently lists 43 devices for Cook Ob/Gyn. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cook Ob/Gyn's devices?
Among its 43 most recently registered devices, Cook Ob/Gyn has devices listed in FDA 510(k) (43 devices).
What risk classes do Cook Ob/Gyn's devices fall under?
Among its 43 most recently registered devices, the classes recorded for Cook Ob/Gyn's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cook Ob/Gyn?
FDA recall records list 1 recall initiated by Cook Ob/Gyn, the most recent initiated on 2 Apr 2009. 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 Ob/Gyn in the registry?
The most recently registered devices listed for Cook Ob/Gyn include STAMEY NEEDLE, TUBAL LUMEN SUPPORT, SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER and BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500.