510(k) clearances

Fecobionics Anorectal System

Gi Bionics, LLC · Gastroenterology, Urology

K242666Substantially EquivalentTraditionalKLA
Open FDA's page for this record
Third party flag
N
City
San Diego
Advisory committee description
Gastroenterology, Urology
Address 1
11107 Roselle St.
Address 2
Suite 213
Statement or summary
Summary
Product code
KLA
Zip code
92121
Applicant
Gi Bionics, LLC
Decision date
2025-02-12
Decision code
SESE
Country code
US
Device name
Fecobionics Anorectal System
Advisory committee
GU
Contact
Ricardo Villanueva
K number
K242666
State
CA
Date received
2024-09-05
Review advisory committee
GU
Postal code
92121
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1725
Device class
2
Registration number
3008414621, 2134626, 3009445917, 3017448360, 9611668, 1836324, 3012159165, 3004743815, 3010170586, 2023374, 2518897, 3007708502, 3006680097, 3012266672, 2183613
FEI number
3003007911, 3002807135, 3008414621, 3002998595, 3017448360, 3012159165, 3004743815, 3010170586, 2023374, 1000080301, 3007708502, 3006680097, 3012266672, 2183613, 3009293069
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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.