510(k) K260984
K260984 is an FDA 510(k) premarket notification submitted by Axora Medical, Inc. for the device "HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)". The FDA issued a decision of Substantially Equivalent on August 18, 2026. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2026
- Date Received
- March 25, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hysteroscope (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1690
- Review Panel
- OB
- Submission Type