• 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 hysteroscope (and accessories)
510(k) Number K200038
Device Name Endosee System
CooperSurgical, Inc.
95 Corporate Drive
Trumbull,  CT  06611
Applicant Contact Christine Kupchick
CooperSurgical, Inc.
95 Corporate Drive
Trumbull,  CT  06611
Correspondent Contact Christine Kupchick
Regulation Number884.1690
Classification Product Code
Subsequent Product Code
Date Received01/08/2020
Decision Date 02/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No