510(k) clearances

cCeLL - In vivo

VPIX Medical, Inc. · Neurology

K260315Substantially EquivalentTraditionalGWG
Open FDA's page for this record
Third party flag
N
City
Daejeon
Advisory committee description
Neurology
Address 1
774, Gyeryong-Ro, Jung-Gu
Statement or summary
Summary
Product code
GWG
Zip code
34873
Applicant
VPIX Medical, Inc.
Decision date
2026-10-16
Decision code
SESE
Country code
KR
Device name
cCeLL - In vivo
Advisory committee
NE
Contact
Kyungmin Hwang
K number
K260315
Date received
2026-01-30
Review advisory committee
NE
Postal code
34873
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Endoscope, Neurological
Medical specialty description
Neurology
Regulation number
882.1480
Device class
2
Registration number
3016050940, 3015615738, 3001592626, 1000343527, 9610612, 3004608878, 3018094310, 3028006458, 3013247477, 3004542960, 3007303113, 9614945, 2432235, 9610617, 3015449142, 3004644065, 1219913, 3005809810, 3008837339, 2183744, 3010202439, 3012322232, 2020550, 3003418325, 3009420598, 2244478, 3016099036, 9611102, 3010707607, 8020888, 8010418, 3008253300, 1418479, 8010487, 9615010, 8044098, 3013758550, 3002807090, 3015967359, 2183911 +30 more
FEI number
3016050940, 3004028763, 3015615738, 1000343527, 3001592626, 3004207793, 3018094310, 3013247477, 3028006458, 3004542960, 3002808001, 3007303113, 2432235, 3015449142, 3004644065, 1219913, 3005809810, 3008837339, 3002808273, 2183744, 3012322232, 2020550, 3002806315, 3003418325, 3009420598, 3007475226, 3016099036, 3010707607, 3008253300, 1418479, 1000306431, 1000116142, 3013758550, 3007130719, 3015967359, 3014342096, 3025341449, 1000453845, 3013505638, 3016591327 +30 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.