510(k) clearances

Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection)

Vein 360 · Gastroenterology, Urology

K260708Substantially EquivalentTraditionalFGB
Open FDA's page for this record
Third party flag
N
City
Cincinnati
Advisory committee description
Gastroenterology, Urology
Address 1
4460 Lake Forest Dr.
Address 2
Suite 218
Statement or summary
Summary
Product code
FGB
Zip code
45242
Applicant
Vein 360
Decision date
2026-10-20
Decision code
SESE
Country code
US
Advisory committee
GU
Contact
Suzanne Meyer
K number
K260708
State
OH
Date received
2026-03-04
Review advisory committee
GU
Postal code
45242
Decision description
Substantially Equivalent
Clearance type
Traditional
Device name

Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection)

Harmonized identifiers (openFDA)
Device name
Ureteroscope And Accessories, Flexible/Rigid
Medical specialty description
Gastroenterology, Urology
Regulation number
876.1500
Device class
2
Registration number
3025349506, 3013247477, 8010047, 3042940358, 3029981244, 8010298, 1000484830, 3012322232, 3019807891, 2531475, 9616693, 3010707607, 9610773, 1418479, 3033010858, 3022106566, 3003782610, 3008439484, 3035484431, 3004111573, 3002808148, 9611612, 2936485, 9614434, 3011986317, 9610877, 3028058843, 3024021261, 3008998256, 1221826, 3020369549, 3011050570, 3003542872, 9610617, 1000121056, 3014683069, 3013992977, 1820334, 3010202439, 3037966040 +80 more
FEI number
3003448211, 3025349506, 3013247477, 3006149253, 3002806565, 3042940358, 3029981244, 3002808273, 1000484830, 3012322232, 3019807891, 3002807847, 3010707607, 3008185830, 1418479, 3033010858, 3022106566, 3003782610, 3008439484, 3035484431, 3004111573, 3002808148, 3000206435, 3002808268, 2936485, 4430, 3011986317, 1000138054, 3028058843, 3024021261, 3002806359, 3008998256, 1221826, 3020369549, 3011050570, 3003542872, 1000121056, 3014683069, 3013992977, 1820334 +80 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.