Herniorraphy Kit
The Herniorraphy Kit is a surgical convenience kit bundling supplies used during herniorraphy, the surgical repair of a hernia, in general and plastic surgery settings. It is classified as a Class 1 device under regulation 878.4800, subject to general controls only, 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 PXW, 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
- PXW
- 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 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.