Suprapubic Cystostomy Catheter Kit
The Suprapubic Cystostomy Catheter Kit (product code NWP) is a surgical convenience kit used for suprapubic cystostomy procedures, providing access to the bladder through the abdominal wall, regulated under 21 CFR 876.5090 in the Gastroenterology and Urology specialty. As a Class 2 convenience kit under the May 1997 Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) to market if all criteria in the guidance are met. The device has no implant or life-sustaining flags.
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Basic Information
- Product Code
- NWP
- Device Class
- FDA class 2
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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.