• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name cystoscope and accessories, flexible/rigid
510(k) Number K193095
Device Name Ambu aScope 4 Cysto
Ambu A/S
Baltorpbakken 13
ballerup,  DK 2750
Applicant Contact anita fjaestad
Ambu Inc.
6230 Old Dobbin Lane, Suite 250
columbia,  MD  21045
Correspondent Contact sanjay parikh
Regulation Number876.1500
Classification Product Code
Date Received11/07/2019
Decision Date 04/02/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No