Laparoscopic Cholecystectomy Kit
The Laparoscopic Cholecystectomy Kit is a surgical convenience kit containing instruments and supplies used for laparoscopic removal of the gallbladder, established under the FDA's May 1997 Convenience Kits Interim Regulatory Guidance. It is an FDA Class 1 device regulated under 21 CFR 878.4800, and does not require a premarket notification (510(k)) to market if it meets all guidance criteria. The product code is PKE, within the General and Plastic Surgery (SU) specialty. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PKE
- 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.