Suprapubic Catheter Accessories
The Suprapubic Catheter Accessories are manual devices used to facilitate the placement of a suprapubic catheter, including introducers, access dilators, and peel-away sheaths. They are classified as FDA Class 1, with no premarket notification required, under regulation 876.5100 in the Gastroenterology and Urology specialty. The product code is QGC. These accessories are not themselves implants and are not life-sustaining.
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Basic Information
- Product Code
- QGC
- Device Class
- FDA class 1
- Regulation Number
- 876.5100
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.