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 Hysteroscope (And Accessories)
510(k) Number K260984
Device Name HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)
Applicant
Axora Medical, Inc.
1 Independent Dr. Suite 2300
Jacksonville,  FL  32202
Applicant Contact Kimberly Marquez
Correspondent
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego,  CA  92129
Correspondent Contact Natalie Kennel
Regulation Number884.1690
Classification Product Code
HIH  
Date Received03/25/2026
Decision Date 08/18/2026
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
-
-