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

TPLC - Total Product Life Cycle

  • 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 hemorrhoid prevention pressure wedge
Regulation Description Hemorrhoid prevention pressure wedge.
Definition Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.
Product CodeOOA
Regulation Number 884.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
PLEXUS BIOMEDICAL INC.
  GRANTED 1

-
-