Endoscopic Shunt Placement Kit
The Endoscopic Shunt Placement Kit is a neurology convenience kit used to facilitate the endoscopic placement of neurosurgical shunts, typically for the treatment of hydrocephalus by diverting excess cerebrospinal fluid. Product code PVL is established as a convenience kit under FDA's 1997 Convenience Kits Interim Regulatory Guidance and is under enforcement discretion, meaning it does not require a premarket notification (510(k)) if it meets all criteria in the guidance. Under regulation 21 CFR 882.5550, it is a Class II device subject to general and special controls. It falls under the Neurology medical specialty and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PVL
- Device Class
- FDA class 2
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Review Panel
- NE
- 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.