510(k) clearance

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)

FDA 510(k) source

510(k) number

K260984

Applicant

Axora Medical, Inc.

Decision date

Aug 18, 2026

Date received

Mar 25, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

HIH

Device type

Hysteroscope (And Accessories)

Device class

Class II

Regulation

21 CFR 884.1690

Advisory committee

Obstetrics/Gynecology

Statement or summary

Summary

Third party

N

Location

Jacksonville, FL, US