Pudendal Anesthesia Kit
The Pudendal Anesthesia Kit is an obstetrics/gynecology convenience kit containing supplies used to administer pudendal nerve blocks, which provide local anesthesia to the perineum and lower vagina during childbirth, episiotomy repair, or other perineal procedures. Product code PVW is established as a convenience kit under FDA's 1997 Convenience Kits Interim Regulatory Guidance and is under enforcement discretion, not requiring a 510(k) if all guidance criteria are met. Under regulation 21 CFR 884.5100, it is a Class II device subject to general and special controls. It falls under the Obstetrics/Gynecology medical specialty and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PVW
- Device Class
- FDA class 2
- Regulation Number
- 884.5100
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- 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.