Device Listing 1402413154

Listing Summary#

Listing key
1402413154
Premarket submission
K231774
Device
CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)
Applicant
MacroLux Medical Technology Co., Ltd.
Product code
FGB
Decision date
2024-01-11