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HTx Disposable Hysteroscope System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231260
510(k) Type
Traditional
Applicant
Suzhou AcuVu Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
3/5/2024
Days to Decision
309 days
Submission Type
Summary

HTx Disposable Hysteroscope System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231260
510(k) Type
Traditional
Applicant
Suzhou AcuVu Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
3/5/2024
Days to Decision
309 days
Submission Type
Summary