HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)— 510(k) K260984

Name: FDA 510(k) clearance K260984
Creator: U.S. Food and Drug Administration
Published: 2026-08-18

Substantially Equivalent

Axora Medical, Inc.

FDA 510(k) clearance K260984 for HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK), Substantially Equivalent on 2026-08-18. Applicant: Axora Medical, Inc.. Device class: 2.

Clearance details

Device name as filed: HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)
Applicant: Axora Medical, Inc.
Product code: Code HIH
Device class: Class 2
Regulation: 21 CFR 884.1690
Advisory panel: Obstetrics/Gynecology
Date received: 2026-03-25
Decision date: 2026-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.