• 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 culdoscope (and accessories)
510(k) Number K180429
Device Name Advincula Delineator Uterine Manipulator
CooperSurgical, Inc.
95 Corporate Dr
Trumbull,  CT  06611
Applicant Contact Roaida Johnson
CooperSurgical, Inc.
95 Corporate Dr
Trumbull,  CT  06611
Correspondent Contact Roaida Johnson
Regulation Number884.1640
Classification Product Code
Date Received02/16/2018
Decision Date 03/14/2018
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
Recalls CDRH Recalls