Foley Catheter Kit (Excludes Hiv Testing)
The Foley Catheter Kit is a convenience kit used in urological procedures, combining a Foley catheter with associated supplies needed for urinary catheterization. It falls under FDA Class 2 (Gastroenterology, Urology specialty), regulated under 21 CFR 876.5130, which normally requires a 510(k) premarket notification. However, per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, this kit is under enforcement discretion and does not require a 510(k) submission if it meets all criteria in that guidance. Product code PPB; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PPB
- Device Class
- FDA class 2
- Regulation Number
- 876.5130
- 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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.