Balloon Uterine Stent

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K952527 ↗

FDA Product Code

KNA

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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• Pgd-Pre-Implantation Genetic Diagnostic Pipettes (Biopsy Pipettes)

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See all devices from Cook Urological, Inc. →

• What clinical procedures is the Balloon Uterine Stent primarily used to assist with within the uterine cavity?

  The Balloon Uterine Stent is designed to assist with intrauterine procedures such as diagnostic evaluations or therapeutic interventions. Its inflatable silicone balloon provides controlled dilation or support, facilitating access during procedures like hysteroscopy or other minimally invasive uterine interventions. The semirigid, angled design also helps navigate the cervical canal more effectively.

• Is the Balloon Uterine Stent intended for single-use or reusable applications, and what does this mean for maintenance?

  The Balloon Uterine Stent is explicitly supplied as a reusable medical instrument, meaning it is engineered for repeated use in controlled clinical settings like outpatient clinics or operating rooms. Reusability requires strict adherence to manufacturer-provided cleaning, sterilization, and handling protocols to ensure patient safety and device integrity between uses.

• How is sterility maintained for the Balloon Uterine Stent, and why is this important?

  Sterility of the Balloon Uterine Stent is critical for safe use, as it is intended for invasive procedures within the uterine cavity. The device must be sterilized per manufacturer instructions before each reuse to prevent infection. Since it is reusable, proper sterilization (e.g., autoclave or chemical sterilization) is mandatory to eliminate pathogens and maintain clinical efficacy, reducing risks like endometritis or sepsis during procedures.

• What regulatory pathway was followed for FDA clearance of the Balloon Uterine Stent, and what does this classification imply for its oversight?

  The Balloon Uterine Stent received FDA clearance through a Traditional 510(k) pathway (K952527), demonstrating it was deemed *substantially equivalent* to a legally marketed predicate device. As a Class II device under product code KNA, it is subject to general controls and special controls specific to obstetric-gynecologic instruments, including performance standards and post-market surveillance to ensure safety and effectiveness in its intended clinical applications.

• Are there specific storage requirements for the Balloon Uterine Stent to preserve its functionality and sterility?

  While the provided data does not detail exact storage conditions, reusable medical instruments like the Balloon Uterine Stent generally require protection from moisture, dust, and physical damage. The manufacturer’s instructions (not specified here) likely recommend storing the device in a clean, dry environment—preferably in its original packaging or a sterile barrier—until sterilization for reuse. Proper storage prevents degradation of materials (e.g., silicone balloon) and maintains readiness for clinical procedures.