Vaginal Examination Tray
The Vaginal Examination Tray is an obstetrics/gynecology convenience kit containing the instruments and supplies needed to perform a pelvic or vaginal examination, including specula, swabs, and collection materials for specimen gathering during routine gynecological assessments. Product code PVX 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 884.4530, 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.
Basic Information
- Product Code
- PVX
- Device Class
- FDA class 2
- Regulation Number
- 884.4530
- 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 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.