510(k) clearances

EzVu Visual Vasopressor injector (EV-19)

Veol Medical Technologies Pvt , Ltd. · Gastroenterology, Urology

K241595Substantially EquivalentTraditionalFBK
Open FDA's page for this record
Third party flag
N
City
Navi Mumbai
Advisory committee description
Gastroenterology, Urology
Address 1
A 747, Midc Pawane, Ttc Industrial Area, Kopar Khairane,
Statement or summary
Summary
Product code
FBK
Zip code
400705
Applicant
Veol Medical Technologies Pvt , Ltd.
Decision date
2025-02-27
Decision code
SESE
Country code
IN
Device name
EzVu Visual Vasopressor injector (EV-19)
Advisory committee
GU
Contact
Sneha Pandit
K number
K241595
Date received
2024-06-03
Review advisory committee
OB
Postal code
400705
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Endoscopic Injection Needle, Gastroenterology-Urology
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1500
Device class
2
Registration number
3008048800, 3010288205, 3035434483, 3007699067, 3021023752, 1220592, 8010047, 3007156625, 3007695959, 2183446, 3010707607, 3015042209, 3003814961, 3021632375, 3017178358, 3013526170, 1722746, 3004837686, 3006621103, 2246552, 3046205723, 1037905, 1056129, 3011050570, 9610617, 1000121056, 1820334, 3010202439, 3015142721, 3017448360, 9614641, 3010273872, 3006750742, 3043141270, 1528319, 3008797804, 3005099803, 1222168, 3004129994, 3000279801 +59 more
FEI number
3008048800, 3010288205, 3035434483, 3007699067, 3002806565, 3021023752, 1220592, 3002995060, 3002807917, 3007695959, 2183446, 3010707607, 2523865, 3015042209, 3003814961, 3021632375, 3017178358, 3013526170, 3004837686, 3002808268, 3006621103, 2246552, 3002806920, 3046205723, 1037905, 3011050570, 1000121056, 1820334, 3015142721, 3007475226, 3017448360, 3010273872, 3006750742, 3043141270, 1000306139, 3008797804, 3005099803, 1222168, 3004129994, 3000279801 +59 more
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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.