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 Culdoscope (And Accessories)
510(k) Number K243152
Device Name GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
Applicant
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact Apeksha Shanbhag
Correspondent
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact Apeksha Shanbhag
Regulation Number884.1640
Classification Product Code
HEW  
Date Received09/30/2024
Decision Date 10/02/2025
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
-
-