Breast Biopsy / Localization Tray
The Breast Biopsy / Localization Tray is a convenience kit bundling supplies used by surgeons for breast biopsy and localization procedures, typically employed in the diagnosis of breast lesions or malignancies. It is classified as a Class 1 device under regulation 878.4800, subject to general controls, and per the FDA's May 1997 convenience kits guidance, it is under enforcement discretion and does not require a 510(k) premarket notification if all criteria in the guidance are met. The product code is PXP, and it falls within the General, Plastic Surgery (SU) medical specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PXP
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- 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 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.