Roller Electrode
by Olympus America, Inc. 2 variants
510(k) K954488
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954488 | Date6 Mar 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1690
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Roller Electrode 24 to 26 Fr is a disposable electrode designed for use with hysteroscope systems. It is classified as an accessory for hysteroscopic procedures and is intended for tissue resection or coagulation during gynecological interventions, particularly in the uterine cavity. The roller ball tip facilitates precise cutting and ablation of tissue while minimizing trauma to surrounding structures.
This device is supplied sterile and intended for single-use only. It is compatible with saline-based resection systems and is classified under FDA device class II (HIH product code). The roller electrode is packaged in sterile packs, typically containing six units, and must be stored under controlled conditions to maintain sterility. Its use is regulated under FDA 510(k) clearance (K954488) and is intended for obstetrics and gynecology applications.
Other devices from Olympus America, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Olympus Roller Electrode 24–26 Fr designed for?
The Roller Electrode 24–26 Fr is specifically designed as a disposable accessory for hysteroscopic procedures. It facilitates precise tissue resection or coagulation within the uterine cavity, minimizing trauma to surrounding structures. The roller ball tip enhances control during these interventions, making it ideal for gynecological surgeries where accuracy is critical.
How is the Roller Electrode 24–26 Fr supplied and stored?
This device is supplied sterile in packs containing six single-use units. To maintain sterility, it must be stored under controlled conditions as specified by the manufacturer. Improper storage could compromise its integrity, so adherence to storage guidelines is essential for clinical use.
Is the Roller Electrode 24–26 Fr compatible with specific resection systems?
Yes, the Roller Electrode 24–26 Fr is designed to be compatible with saline-based resection systems. This compatibility ensures effective tissue ablation or coagulation during hysteroscopic procedures, reducing the risk of complications associated with non-compatible fluid systems.
What regulatory pathway does the Roller Electrode 24–26 Fr follow?
The Roller Electrode 24–26 Fr is classified under FDA device class II (HIH product code) and has obtained FDA 510(k) clearance (K954488). This clearance confirms its substantial equivalence to a predicate device and ensures it meets regulatory standards for obstetrics and gynecology applications.
Why is the Roller Electrode 24–26 Fr intended for single-use only?
The Roller Electrode 24–26 Fr is designed for single-use to ensure patient safety and sterility. Reuse could introduce contamination risks, compromise precision, or damage the electrode’s functionality. Single-use devices like this minimize cross-infection hazards and maintain consistent performance for optimal clinical outcomes.