Silicone Rectal Balloon
by Cook Urological, Inc. 510(k)
Active
510(k) K930135
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930135 | Date8 Oct 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FEN
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1620
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Silicone Rectal Balloon is a Cystometric, Hydraulic Device designed for urological and gastroenterological assessment. It is used to measure bladder pressure and capacity by inflating a silicone balloon within the rectum, providing data for diagnostic evaluation of bladder function and lower urinary tract dynamics. The device aids in assessing conditions such as urinary incontinence, neurogenic bladder, or voiding dysfunction through controlled pressure testing.
This single-use, non-sterile device is intended for use in clinical settings where cystometry is performed. It is supplied as a sterile product upon packaging and must be handled according to standard aseptic techniques. The balloon is available in various French sizes (as referenced in related product codes) and is regulated under FDA 510(k) clearance (K930135) under the classification of Class II medical devices (regulation number 876.1620). No MRI safety information is specified, and it is not intended for reusable applications.
Other devices from Cook Urological, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Silicone Rectal Balloon used for?
The Silicone Rectal Balloon is a cystometric, hydraulic device designed for urological and gastroenterological assessment. It measures bladder pressure and capacity by inflating a silicone balloon within the rectum, providing critical data for diagnosing conditions like urinary incontinence, neurogenic bladder, or voiding dysfunction. This controlled pressure testing helps clinicians evaluate lower urinary tract dynamics.
Is the Silicone Rectal Balloon sterile and single-use?
Yes, the Silicone Rectal Balloon is supplied as a sterile product upon packaging, ensuring safety for clinical use. It is explicitly designed for single-use only, meaning it should not be reused after a single procedure. This aligns with standard aseptic techniques required in cystometry procedures.
What sizes are available for the Silicone Rectal Balloon?
The Silicone Rectal Balloon is available in various French sizes, as referenced in the related product codes. French sizes are a standard measurement for medical devices, particularly those used in urology and gastroenterology, ensuring compatibility with different patient anatomies and clinical needs.
How should the Silicone Rectal Balloon be stored?
Since the Silicone Rectal Balloon is supplied sterile, it must be stored according to standard sterile product guidelines. This includes keeping it in its original, unopened packaging until ready for use, protecting it from contamination, and adhering to manufacturer recommendations for shelf life and environmental conditions.
Can the Silicone Rectal Balloon be reused?
No, the Silicone Rectal Balloon is explicitly intended for single-use only. Reusing it could compromise sterility and patient safety, leading to potential complications. Always follow the manufacturer’s instructions to ensure proper use and compliance with clinical protocols.