Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories
The Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories are manual devices designed for surgical procedures associated with the implantation of mechanical or hydraulic urinary continence devices, including measurement tools, connector assembly tools, tubing plugs, incision closing tools, tubing passers, blunt needles, and hemostat shod tubing. They are classified as FDA Class 1, with no premarket notification required, under regulation 876.5290 in the Gastroenterology and Urology specialty. The product code is QGD. These accessories are not themselves implants.
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Basic Information
- Product Code
- QGD
- Device Class
- FDA class 1
- Regulation Number
- 876.5290
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
Definition
Implanted mechanical/hydraulic urinary continence device surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the measurement tool or tape, connector assembly tool, tubing plug, incision closing tool, tubing passer, blunt needle, and hemostat shod tubing.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.