Ostomy Care Kit
The Ostomy Care Kit is a convenience kit containing supplies used for the care and management of an ostomy (a surgically created opening in the body for waste elimination), falling under the Gastroenterology and Urology specialty. It is classified as FDA Class 1 under 21 CFR 876.5900, subject only to general controls. Per the FDA's 1997 Convenience Kits Interim Regulatory Guidance, this type of kit is under enforcement discretion and does not require a 510(k) premarket notification if it meets all applicable criteria. Product code PQE; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQE
- Device Class
- FDA class 1
- Regulation Number
- 876.5900
- 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.