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Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
HDX
Dilator, Vaginal
2
Product Code
HFJ
Prosthesis, Fallopian Tube
2
Product Code
HFK
Mold, Vaginal
2
Product Code
HFL
Drain, Cervical
2
Product Code
HHW
Pessary, Vaginal
2
Product Code
K
23
2677
Reia pessary
2
Cleared 510(K)
K
23
2525
Yoni.Fit Bladder Support
2
Cleared 510(K)
K
23
3548
Uresta®
2
Cleared 510(K)
K
23
1786
Gynethotics™ Pessary
2
Cleared 510(K)
K
19
0277
ProVate Vaginal Support
2
Cleared 510(K)
K
18
3468
Revive Reusable Bladder Support
2
Cleared 510(K)
K
17
3351
Panpac Flexi Shelf Pessary
2
Cleared 510(K)
K
15
3422
Panpac Disposable Pessary Fitting Set
2
Cleared 510(K)
K
15
1413
Always/Tampax bladder supports
2
Cleared 510(K)
K
13
2313
PESSARY
2
Cleared 510(K)
Show All 38 Submissions
KXP
Stent, Vaginal
2
Product Code
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
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Review Panel
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Review Panel
Last synced on 6 December 2024 at 11:05 pm
OB
/
subpart-d—obstetrical-and-gynecological-prosthetic-devices
/
HHW
/
K231786
View Source
Gynethotics™ Pessary
Page Type
Cleared 510(K)
PDF
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
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
HDX
Dilator, Vaginal
HFJ
Prosthesis, Fallopian Tube
HFK
Mold, Vaginal
HFL
Drain, Cervical
HHW
Pessary, Vaginal
K
23
2677
Reia pessary
K
23
2525
Yoni.Fit Bladder Support
K
23
3548
Uresta®
K
23
1786
Gynethotics™ Pessary
K
19
0277
ProVate Vaginal Support
K
18
3468
Revive Reusable Bladder Support
K
17
3351
Panpac Flexi Shelf Pessary
K
15
3422
Panpac Disposable Pessary Fitting Set
K
15
1413
Always/Tampax bladder supports
K
13
2313
PESSARY
Show All 38 Submissions
KXP
Stent, Vaginal
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-d—obstetrical-and-gynecological-prosthetic-devices
/
HHW
/
K231786
View Source
Gynethotics™ Pessary
Page Type
Cleared 510(K)
PDF
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