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United States FDA 510(k) clearance K231774Substantially Equivalent

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)

United StatesClass 2MacroLux Medical Technology Co., Ltd.Cleared Jan 11, 2024
Verified
Clearance details
K-Number
K231774
View FDA 510(k) Summary PDF View on FDA Database
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Product Code
FGB
View Product Code Classification
Device Class
Class 2
Clearance Type
Traditional
Regulation Number
876.1500
View CFR Regulation
Applicant information
Applicant
MacroLux Medical Technology Co., Ltd.
Contact
Linbin Ye
Location
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Guangming
Shenzhen 518107
CN
Medical classification
Medical Specialty
Gastroenterology, Urology
Advisory Committee
GU
Dates and decision
Date Received
Jun 16, 2023
Decision Date
Jan 11, 2024
Decision
Substantially Equivalent
Statement / Summary

Summary

About this record

Access comprehensive regulatory information for 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) in the USA medical device market through Pure Global AI's free database. This Class 2 medical device was cleared under FDA 510(k) number K231774 and submitted by MacroLux Medical Technology Co., Ltd.. The clearance decision was Substantially Equivalent on Jan 11, 2024.

This page provides complete clearance details including product code FGB, medical specialty classification (Gastroenterology, Urology), and regulatory compliance information from the official FDA OpenFDA database. Pure Global AI offers free access to FDA 510(k) clearances from 1976 to present, helping global MedTech companies navigate USA FDA regulations efficiently.