Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- NRZAblation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided3Product Code
- OVXWater Immersion Labor PoolNProduct Code
- PASRf/Microwave Hyperthermia System, Cancer TreatmentFProduct Code
- HHYProsthesis, Suture, Cerclage3Product Code
- LHDDevice, Fertility Diagnostic, ProceptiveUProduct Code
- LLQCap, Cervical, Contraceptive3Product Code
- LLXCatheter, Sampling, Chorionic Villus3Product Code
- LOBDilator, Cervical, Synthetic, Osmotic, Pregnancy Termination3Product Code
- LTAFluid, Hysteroscopy3Product Code
- LTYFluid, Cytological Collection3Product Code
- MCIGraft, Vascular, Hemodialysis Access, Synthetic/Biological Composite3Product Code
- MCNBarrier, Absorbable, Adhesion3Product Code
- MCPStimulator, Fetal, Acoustic3Product Code
- MGIAspirator, Ultrasonic3Product Code
- MKNCatheter, Balloon, Transcervical3Product Code
- MMAOximeter, Fetal Pulse3Product Code
- MNBDevice, Thermal Ablation, Endometrial3Product Code
- MPRStent, Bladder, FetalFProduct Code
- MPTContraception CalculatorUProduct Code
- MWMSensor, Electro-Optical (For Cervical Cancer)3Product Code
- PKFD And C TrayNProduct Code
- QLHSystem, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber LedNProduct Code
- QRZExternal Condom For Anal Intercourse Or Vaginal Intercourse2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
D And C Tray
- Page Type
- Product Code
- 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.
- Physical State
- 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.
- Technical Method
- 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.
- Target Area
- 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.
- Review Panel
- Obstetrical and Gynecological
- Submission Type
- Enforcement Discretion
- Device Classification
- N
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
As product code PKF is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.