Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Laparoscope, Gynecologic (And Accessories)
510(k) Number K201617
Device Name TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))
Applicant
Schoelly Fiberoptic GmbH
Robert-Bosch-Strasse 1-3
Denzlingen,  DE 79211
Applicant Contact Sandra Baumann
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact Pamela Papineau
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
FET   GCJ  
Date Received06/15/2020
Decision Date 03/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-