Last synced on 30 September 2022 at 11:05 pm

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
K211227
510(k) Type
Traditional
Applicant
AcuVu Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/15/2021
Days to Decision
145 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
K211227
510(k) Type
Traditional
Applicant
AcuVu Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/15/2021
Days to Decision
145 days
Submission Type
Summary