Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
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- MiscellaneousMiscellaneous
- 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
- HDXDilator, Vaginal2Product Code
- K241748Intimate Rose Vaginal Dilators2Cleared 510(K)
- K233689Hope&Her Vaginal Dilators2Cleared 510(K)
- K222492Hope&Her Vaginal Dilators2Cleared 510(K)
- K231430Intimate Rose Vaginal Dilators2Cleared 510(K)
- K220035Milli Vaginal Dilator2Cleared 510(K)
- K211959Milli Vaginal Dilator2Cleared 510(K)
- K130273PANPAC VAGINAL DILATORS2Cleared 510(K)
- K071754NEO-VAGINA SURGERY SET AND ACCESSORIES2Cleared 510(K)
- K003380BIOTEQUE VAGINAL DILATOR2Cleared 510(K)
- HFJProsthesis, Fallopian Tube2Product Code
- HFKMold, Vaginal2Product Code
- HFLDrain, Cervical2Product Code
- HHWPessary, Vaginal2Product Code
- KXPStent, Vaginal2Product Code
- 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
Hope&Her Vaginal Dilators
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K233689
- 510(k) Type
- Traditional
- Applicant
- Lujena, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/2/2024
- Days to Decision
- 167 days
- Submission Type
- Statement