| Device |
foley catheters and accessories with additional safety features |
| Regulation Description |
Urological catheter and accessories. |
| Definition |
Foley catheters intended for urine drainage with additional safety features to reduce potential injury to the urethra and/or bladder. These catheters do not include design features intended to reduce infections. |
| Physical State |
This generic type of device includes Foley catheters (semi-flexible plastic tube with retention balloon) for urine drainage from bladder into a urine bag with additional safety features, such as catheter parts and/or accessories to reduce potential injury. |
| Technical Method |
Includes features to reduce potential injury to the urethra and/or bladder such as during insertion, use or withdrawal of the catheter. Examples include an accessory to reduce friction between urethral tissue and catheter (other than a coating) or an integrated mechanism or accessory (e.g., valve) for retention balloon inflation/deflation. |
| Target Area |
Lower urinary tract, urinary bladder, and urethra. |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | SCT |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5130
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
