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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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231774
510(k) Type
Traditional
Applicant
MacroLux Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/11/2024
Days to Decision
209 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231774
510(k) Type
Traditional
Applicant
MacroLux Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
1/11/2024
Days to Decision
209 days
Submission Type
Summary