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FDA 510(k)

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

K-Number: K260984 · 2026-08-18

ApplicantAxora Medical, Inc.
Decision Date2026-08-18
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) is the device name listed in this FDA 510(k) record. The listed applicant is Axora Medical, Inc.. It received FDA 510(k) clearance on 2026-08-18 under 510(k) number K260984. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)?

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) is a medical device that received FDA 510(k) clearance on 2026-08-18. The listed applicant is Axora Medical, Inc.. The 510(k) number is K260984.

When did HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) receive FDA 510(k) clearance?

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) received FDA 510(k) clearance on 2026-08-18, under 510(k) number K260984.

Who is the listed applicant for HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)?

The FDA 510(k) record lists Axora Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)?

The FDA product code for HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) is HIH.

Other records listing Axora Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P140013Device, thermal ablation, endometrialPMA P000040Device, thermal ablation, endometrial

Related Devices (Code: HIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253020Strauss Surgical Resection InstrumentsAmerican Medical Endoscopy, Inc.K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.K254251InnovexView (GC146-17, GC150-20, GC155-23)Shanghai AnQing Medical Instrument Co., Ltd.K252793ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)Jiangsu Jiyuan Medical Technology Co., Ltd.K252012SPY Cystoscope/HysteroscopeStryker EndoscopyK243382RZ Resectoscope SystemRz Medizintechnik GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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