D And C Tray
The D And C Tray is a convenience kit associated with dilation and curettage (D&C) procedures, reviewed under the Obstetrics/Gynecology panel. It is classified as not formally classified (Class N) under the FDA's enforcement discretion policy for convenience kits established by the May 1997 Convenience Kits Interim Regulatory Guidance, and therefore does not require a premarket notification (510(k)) to market. The kit is not flagged as an implant or life-sustaining device and carries no formal regulation number.
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Basic Information
- Product Code
- PKF
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Unclassified Reason
6
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.