Cleared Traditional

K260984 - HERizon RD5 Resecting Device (5FR1PK)

Also marketed or referenced as:
HERizon RD5 Resecting Device - 5 pack (5FR5PK)

K260984 is an FDA 510(k) clearance for HERizon RD5 Resecting Device (5FR1PK), manufactured by Axora Medical, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIH cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K260984 · Axora Medical, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
146d
Days
Class 2
Risk

K260984 is an FDA 510(k) clearance for the HERizon RD5 Resecting Device (5FR1PK). Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Axora Medical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 18, 2026 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1690 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Axora Medical, Inc. devices

FDA 510(k) Submission Details - K260984

510(k) Number K260984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2026
Decision Date August 18, 2026
Days to Decision 146 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 160d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIH Device Classification - Class 2, Special Controls

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

NJK & Associates, Inc.
Natalie Kennel

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIH Hysteroscope (and Accessories)

All 143
Devices cleared under the same product code (HIH) and FDA review panel - the closest regulatory comparables to K260984.
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