Gyrus Endourology System: AxiPolar Resectoscope Loop Electrode
510(k) K001270
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK001270 | Date28 Apr 2000 | 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- Withdrawn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
- FJL
- FDA applicant
- Gyrus Medical , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Gyrus Endourology System: AxiPolar Resectoscope Loop Electrode is a resectoscope loop electrode, a component of an electrosurgical system designed for transurethral resection procedures. It delivers precise monopolar electrosurgical energy to remove or resect tissue within the urinary tract, including the bladder, prostate, or urethra, under direct visual guidance via a cystoscope or resectoscope.
This device is supplied as a single-use, sterile electrode loop intended for use in urological and gastroenterological settings. It is classified as a Class II medical device under FDA regulations (876.1500) and requires FDA 510(k) clearance for commercial distribution. The electrode is compatible with MRI environments when used as directed, and its design adheres to standards for electrosurgical safety in endoscopic procedures. Storage and handling follow standard sterile instrument protocols to maintain integrity before use.
Other devices from Gyrus Medical, Ltd.
Questions
AI-generated answers, 19 Sep 2026
What types of procedures is this resectoscope loop electrode designed for, and how does it work?
The Gyrus Endourology System: AxiPolar Resectoscope Loop Electrode is specifically designed for transurethral resection procedures in the urinary tract, such as bladder, prostate, or urethra tissue removal. It delivers monopolar electrosurgical energy under direct visual guidance via a cystoscope or resectoscope, allowing precise tissue resection while minimizing trauma to surrounding areas. The electrode’s design ensures controlled energy application for safe and effective surgical outcomes.
Is this electrode single-use or reusable, and how should it be stored to maintain sterility?
This electrode is intended for single-use only and is supplied sterile. To preserve sterility before use, it must be stored according to standard sterile instrument protocols—typically in its original, unopened packaging, away from moisture, extreme temperatures, and direct sunlight. Follow manufacturer guidelines to ensure the device remains intact and uncontaminated until use.
What safety considerations should clinicians keep in mind when using this electrode in an MRI environment?
The electrode is compatible with MRI environments when used as directed, meaning it has been designed to minimize risks associated with electromagnetic interference or heating during MRI scans. However, clinicians must adhere to the manufacturer’s instructions for MRI-safe use, including proper grounding and ensuring the electrode is not exposed to high magnetic fields beyond specified limits. Always verify compatibility with your facility’s MRI protocols.
What regulatory pathway was followed for this device’s approval, and which advisory committees were involved?
This device received FDA 510(k) clearance under a Special 510(k) review, classified as Substantially Equivalent (SESE) to a predicate device. The Gastroenterology and Urology (GU) Advisory Committee reviewed the submission, as indicated by the advisory committee description and product code (FJL). The clearance was granted on April 28, 2000, following a thorough evaluation by the FDA.