Last synced on 2 December 2022 at 11:04 pm

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210579
510(k) Type
Traditional
Applicant
OTU Medical Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/22/2021
Days to Decision
146 days
Submission Type
Summary

WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210579
510(k) Type
Traditional
Applicant
OTU Medical Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/22/2021
Days to Decision
146 days
Submission Type
Summary