510(k) clearances

Yoni.Fit Bladder Support

Watkins-Conti Products, Inc. · Obstetrics/Gynecology

K232525Substantially EquivalentTraditionalHHW
Open FDA's page for this record
Third party flag
N
City
Edmond
Advisory committee description
Obstetrics/Gynecology
Address 1
3841 E. Danforth Rd., Suite 109
Statement or summary
Summary
Product code
HHW
Zip code
78084
Applicant
Watkins-Conti Products, Inc.
Decision date
2024-05-17
Decision code
SESE
Country code
US
Device name
Yoni.Fit Bladder Support
Advisory committee
OB
Contact
Allison L Watkins
K number
K232525
State
OK
Date received
2023-08-21
Review advisory committee
GU
Postal code
78084
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Pessary, Vaginal
Medical specialty description
Obstetrics/Gynecology
Regulation number
884.3575
Device class
2
Registration number
3010131137, 3007137643, 3031738269, 3016608162, 3019039128, 8040510, 3007289408, 3003418325, 2951215, 3014295858, 3015895045, 3005674485, 3014755376, 3036802560, 1450908, 3024374351, 3031788248, 3000143502, 3003701733, 3029906631, 2084346, 3020160672, 3015417614, 3013557562, 1216677, 3021815, 1226146, 1123010, 3003968049, 2431166, 2511556, 3011529681, 3009513193, 3024860690, 3025325116, 9680721, 3007421149
FEI number
3010131137, 3007137643, 3031738269, 3016608162, 1000124817, 3019039128, 1000244733, 3007289408, 3001319476, 3003418325, 3014295858, 3015895045, 3005674485, 3014755376, 2523865, 3036802560, 1450908, 3024374351, 1000221492, 1000123297, 3031788248, 3000143502, 3003701733, 3029906631, 3020160672, 3015417614, 3013557562, 1216677, 3021815, 3003968049, 2511556, 3002680121, 3011529681, 3009513193, 3024860690, 3025325116, 3007421149
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.