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
- 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)
- K132670PANPAC INFLATABLE DOCUT PESSARY2Cleared 510(K)
- K131198TIPI OTC2Cleared 510(K)
- K092981PANPAC VAGINAL PESSARY2Cleared 510(K)
- K083769MODIFICATION TO URESTA PESSARY2Cleared 510(K)
- K081385URESTA PESSARY2Cleared 510(K)
- K060526TIPI2Cleared 510(K)
- K032644KOLPEXIN SPHERE2Cleared 510(K)
- K031463MARINA MEDICAL SILICONE PESSARY2Cleared 510(K)
- K020512MTI ST#1 SILICONE PESSARY2Cleared 510(K)
- K012277PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE2Cleared 510(K)
- K013289BIOTEQUE VAGINAL PESSARIES2Cleared 510(K)
- K002329PELVX GELLHORN VAGINAL PESSARY 603-6082Cleared 510(K)
- K993308MENTOR EVACARE VAGINAL PESSARIES2Cleared 510(K)
- K990593PELVX INCONTINENCE DISH, MODEL 301-3062Cleared 510(K)
- K974117PELVX DONUT, PELVX CUBE2Cleared 510(K)
- K974115PELVX RING, PELVX RING WITH SUPPORT2Cleared 510(K)
- K974116PELVX INCONTINENCE RING2Cleared 510(K)
- K965040INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL2Cleared 510(K)
- K933654BLADDER NECK SUPPORT PROTHESIS FITTING KIT2Cleared 510(K)
- K930618VAGINAL CONTINENCE DEVICE2Cleared 510(K)
- K920747PESSARY FLEXIBLE SILICONE DONUT RING2Cleared 510(K)
- K920187FLEXIBLE SILICONE GELIHORN2Cleared 510(K)
- K904774INGLAT-O-BALL2Cleared 510(K)
- K904026INFLAT-O-BALL2Cleared 510(K)
- K890565GELLHORN PESSARY 33410 VARIOUS SIZES2Cleared 510(K)
- K883721FEMALE CONTINENCE DEVICE2Cleared 510(K)
- K781863DEVICE, FEMALE INCONTINENCE2Cleared 510(K)
- K771548SILASTIC BRAND INTRAVAGINAL TARSETTE2Cleared 510(K)
- 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
FLEXIBLE SILICONE GELIHORN
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K920187
- 510(k) Type
- Traditional
- Applicant
- BIOTEQUE AMERICA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/23/1992
- Days to Decision
- 283 days
- Submission Type
- Statement