Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview 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
- HFJProsthesis, Fallopian Tube2Product Code
- HFKMold, Vaginal2Product Code
- HFLDrain, Cervical2Product Code
- HHWPessary, Vaginal2Product Code
- K232677Reia pessary2Cleared 510(K)
- K232525Yoni.Fit Bladder Support2Cleared 510(K)
- K233548Uresta®2Cleared 510(K)
- K231786Gynethotics™ Pessary2Cleared 510(K)
- K190277ProVate Vaginal Support2Cleared 510(K)
- K183468Revive Reusable Bladder Support2Cleared 510(K)
- K173351Panpac Flexi Shelf Pessary2Cleared 510(K)
- K153422Panpac Disposable Pessary Fitting Set2Cleared 510(K)
- K151413Always/Tampax bladder supports2Cleared 510(K)
- K132313PESSARY2Cleared 510(K)
- Show All 38 Submissions
- 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
Gynethotics™ Pessary
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K231786
- 510(k) Type
- Traditional
- Applicant
- Cosm Medical
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/6/2024
- Days to Decision
- 260 days
- Submission Type
- Summary