CoralView® Single-use Digital Flexible Ureteroscope (U10) +5 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K231774

by MacroLux Medical Technology Co., Ltd.

Identifiers

510(k) Number: K231774 FDA 510(k)
FDA Product Code: FGB FDA 510(k)
Models / Variants: CoralView® Single-use Digital Flexible Ureteroscope (U10) FDA 510(k)
CoralView® Single-use Digital Flexible Ureteroscope (U10-B) FDA 510(k)
CoralView® Single-use Digital Flexible Ureteroscope (U10-BR) FDA 510(k)
CoralView® Single-use Digital Flexible Ureteroscope (U20) FDA 510(k)
CoralView® Single-use Digital Flexible Ureteroscope (U20-B) FDA 510(k)
CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 876.1500 FDA 510(k)
Regulation Number: 876.1500 FDA 510(k)
Advisory Committee: Gastroenterology, Urology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

CoralView® Single-use Digital Flexible Ureteroscope (U10) +5 more models by MacroLux Medical Technology Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k)…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K231774	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: MacroLux Medical Technology Co., Ltd.

Sources (1)

FDA 510(k) K231774 24 fields · synced Jun 18, 2026