Biopsy Needle Kit
The Biopsy Needle Kit (product code POZ) is a Class 2 gastroenterology and urology convenience kit established under the FDA's Convenience Kits Interim Regulatory Guidance, regulated under 876.1075. Under enforcement discretion, it does not require a 510(k) to market if it meets all criteria in the guidance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- POZ
- Device Class
- FDA class 2
- Regulation Number
- 876.1075
- 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 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.