HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)— 510(k) K260984
Substantially EquivalentAxora 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.
Summary
Axora Medical's HERizon RD5 Resecting Device has two listed entries: 5FR1PK and a 5 pack, 5FR5PK. It's filed under product code HIH, hysteroscopes and accessories.
Class II, 21 CFR 884.1690. Obstetrics/Gynecology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Axora filed from Jacksonville, Florida. Review took 146 calendar days (March 25 to August 18, 2026) and ended in a substantially equivalent decision.
Clearance details
- Device name as filed
- HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)
- Applicant
- Axora Medical, Inc.
- Product code
- Product code HIH
- Device class
- Class 2
- Regulation
- 21 CFR 884.1690
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Recent devices under product code HIH
view all- K254252 — UNIDRIVE SIII System +1 more
- K261102 — UNIDRIVE Select System
- K254294 — Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
- K253020 — Strauss Surgical Resection Instruments
- K254050 — Manual Tissue Removal Device
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, through . 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.