510(k) clearances

Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector

Cair Lgl · Gastroenterology, Urology

K231299Substantially EquivalentTraditionalPIO
Open FDA's page for this record
Third party flag
N
City
Lissieu
Advisory committee description
Gastroenterology, Urology
Address 1
1, Allée Des Chevreuls
Statement or summary
Summary
Product code
PIO
Zip code
69380
Applicant
Cair Lgl
Decision date
2024-01-22
Decision code
SESE
Country code
FR
Device name
Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector
Advisory committee
GU
Contact
Irving L Wiesen
K number
K231299
Date received
2023-05-04
Review advisory committee
GU
Postal code
69380
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Enteral Specific Transition Connectors
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5980
Device class
2
Registration number
1417592, 3000268902, 3015433750, 3013788631, 3006673317, 3004472854, 3003593728, 9611594, 3007441619, 1526012, 3036722184, 8020785, 3012494290, 1423537, 3001124136, 3023275185, 3038294399, 3012441761, 3014662855, 3031915926, 3011237770, 9612030
FEI number
1417592, 3000268902, 3015433750, 3013788631, 3002806436, 3004472854, 3005596530, 3002806934, 3003593728, 3007441619, 1526012, 3036722184, 3012494290, 3001236905, 3009291251, 3001124136, 3023275185, 3038294399, 3012441761, 3014662855, 3031915926, 3011237770
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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.