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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

Axora Medical Launches HERizon RD5, a 5Fr Battery-Powered Uterine Polyp Resecting Device

The single-use handheld resector, cleared by the FDA in August, fits 5Fr and larger hysteroscopes and is intended for use in the office or the operating room.

By News DeskOctober 27, 20262 min read
Labelled cross-section illustration of a hysteroscope inserted through a speculum and cervix into the uterus
A medical illustration of hysteroscopy, showing a hysteroscope passed through the cervix into the uterus. The HERizon RD5 device is not pictured. BruceBlaus (Blausen Medical), CC BY-SA 4.0, via Wikimedia Commons · CC BY-SA 4.0
FDA cleared510(k) · K260984FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • Axora Medical announced the US launch of the HERizon RD5 Resecting Device on October 27, 2026.
  • The FDA cleared the device through the 510(k) pathway on August 18, 2026, under submission K260984, as a hysteroscope accessory.
  • Axora says the 1.65 mm device has the smallest outer diameter of any powered hysteroscopic tissue resection device on the US market, based on its own review of manufacturer specifications.

Axora Medical has launched the HERizon RD5 Resecting Device in the United States, a single-use, battery-powered handheld device for removing tissue such as endometrial polyps during hysteroscopy, the company announced on October 27.

The FDA's 510(k) database lists submission K260984 for the HERizon RD5 Resecting Device, in single-unit and five-pack configurations, from Axora Medical, Inc. The agency received the traditional 510(k) on March 25, 2026, and found the device substantially equivalent on August 18. It is classified under regulation 884.1690 as a hysteroscope accessory, product code HIH, and was reviewed by the obstetrics and gynecology panel.

According to the company, the device is intended for intrauterine use by physicians trained in hysteroscopy, a procedure in which a thin camera is passed through the cervix to view the inside of the uterus, to resect and remove tissue such as endometrial polyps.

Size and design

Axora said HERizon RD5 measures 5Fr, or 1.65 millimetres, in outer diameter, and described it as having the smallest outer diameter of any powered hysteroscopic tissue resection device on the US market. A footnote in the release says that comparison is based on the company's review of published manufacturer specifications for commercially available devices as of August 20, 2026.

The company listed these features:

  • A built-in battery, so no external console or wall outlet is needed. Axora said the battery has been tested for 10 minutes of continuous use.
  • Compatibility with any 5Fr or larger hysteroscope.
  • A bi-directional rotating mechanical blade with a 5 mm cutting window and a 36.3 cm distal length.
  • A single-use handheld design intended for both office and operating room settings.

Same-visit workflow

Axora framed the launch around abnormal uterine bleeding, which it said often requires one visit to find the cause and another to treat it. Because the device fits small hysteroscopes, the company said, physicians can move from evaluation into treatment during the same procedure.

"By combining a small 5Fr. profile with a handheld, battery-powered design, we are giving physicians another option to move from visualization to treatment within a workflow designed for both the office and the OR," said Darin Hammers, Axora Medical's president and chief executive.

Soheil A-Hanjani, MD, of Hanjani Ob/Gyn in Brockton, Massachusetts, said in the release: "Being able to see pathology is an important first step. The next question is what physicians can do once they identify it."

The device joins Axora's HERizon line, which the company said includes the HERizon Vista ViewPoint endoscopic video image processor and HERizon Vista single-use hysteroscopes. Axora said HERizon RD5 also builds on its Resectr manual resecting device. The company's website lists other gynecology products, including the Minerva EAS, Genesys HTA and Symphion systems.

The release did not include clinical study data for HERizon RD5 or pricing. The announcement was also distributed through ACCESS Newswire, datelined Sunnyvale, California.

Sources

  1. Axora Medical Launches HERizon RD5 Resecting Device, the First 5Fr. Battery-Powered Device for Removing Uterine Polyps, Axora Medical (company newsroom), October 27, 2026
  2. Axora Medical Launches HERizon RD5(R) Resecting Device, the First 5Fr. Battery-Powered Device in the U.S. for Removing Uterine Polyps, ACCESS Newswire, via FinancialContent, October 27, 2026
  3. 510(k) Premarket Notification K260984: HERizon RD5 Resecting Device, US Food and Drug Administration, August 18, 2026