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 Fetal Head Elevator
510(k) Number K243799
Device Name Fetal Pillow
Applicant
Coopersurgical Inc.,
95 Corporate Dr.
Trumbull,  CT  06611
Applicant Contact Irina Fedorov
Correspondent
Coopersurgical Inc.,
95 Corporate Dr.
Trumbull,  CT  06611
Correspondent Contact Irina Fedorov
Regulation Number884.4350
Classification Product Code
PWB  
Date Received12/11/2024
Decision Date 08/29/2025
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
-
-