Penile Implant Surgical Accessories
The Penile Implant Surgical Accessories are a set of manual devices designed for surgical procedures associated with the implantation of penile inflatable or penile rigidity implants, including cylinder sizers, insertion tools, placement tools, connector assembly tools, corporeal dilators, tubing passers, measurement tools, and hemostats. They are classified as FDA Class 1, with no premarket notification required, under regulation 876.3500 in the Gastroenterology and Urology specialty. The product code is QGA. These accessories are not themselves implants.
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Basic Information
- Product Code
- QGA
- Device Class
- FDA class 1
- Regulation Number
- 876.3500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
Definition
Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, blunt needle, and hemostat shod tubing.
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.