510(k) clearances

Reia pessary

Reia, LLC · Obstetrics/Gynecology

K232677Substantially EquivalentTraditionalHHW
Open FDA's page for this record
Third party flag
N
City
Lyme
Advisory committee description
Obstetrics/Gynecology
Address 1
331 River Rd.
Statement or summary
Summary
Product code
HHW
Zip code
03768
Applicant
Reia, LLC
Decision date
2024-05-21
Decision code
SESE
Country code
US
Device name
Reia pessary
Advisory committee
OB
Contact
Kaitlin Maier
K number
K232677
State
NH
Date received
2023-09-01
Review advisory committee
OB
Postal code
03768
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.