| Device |
suprapubic catheter accessories |
| Regulation Description |
Suprapubic catheter accessories. |
| Definition |
Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath. |
| Physical State |
Introducer, access dilator, and peel-away sheath |
| Technical Method |
The accessories are used to aid in placement of suprapubic catheters. |
| Target Area |
Bladder, pubic tissue |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | QGC |
|---|
| Premarket Review |
Reproductive, Gynecology and Urology Devices
(DHT3B)
Reproductive, Gynecology and Urology Devices
(DHT3B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
876.5100
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
