ELRA electrode
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- ELRA electrode EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
- Device Name
- ELRA electrode EUDAMEDThe ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides. FDA UDI
- Model / Reference
- 7-2B11S EUDAMEDFDA UDI
- Description
- The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809306762344 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809306762344 EUDAMED880930676ELRA_EPM EUDAMED
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMEDK0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- France EUDAMEDBulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Shaft Length — 40 Centimeter FDA UDI
The ELRA Electrode is a radiofrequency ablation electrode (Nomenclature Code: K0201010302), designed for tissue coagulation and ablation via controlled delivery of radiofrequency energy. It operates as an active device, interfacing with an RF lesion generator to monitor impedance and tissue temperature during electrosurgical procedures.
Supplied sterile and intended for single-use, the ELRA Electrode is classified as Class IIb under FDA 510(k) clearance (Special, Substantially Equivalent) and MDR compliance. Available in multiple reference sizes (7-2B11S/L, 7-2B22S/L, 7-4B18S/L, 7-4B33S/L), it is non-implantable, non-reusable, and latex-free. UDI: B-08809306762344.
Frequently asked questions
What clinical procedures is the ELRA electrode designed to support, and how does it work during those procedures?
The ELRA electrode is specifically designed for radiofrequency ablation procedures, which involve controlled tissue coagulation and ablation. It interfaces with an RF lesion generator to deliver precise radiofrequency energy, while simultaneously monitoring impedance and tissue temperature. This makes it suitable for procedures in gastroenterology and urology, where targeted tissue destruction is required, such as during ablation of tumors or other lesions.
Are there multiple sizes or models available for the ELRA electrode, and how do I determine which one to use?
Yes, the ELRA electrode comes in multiple reference sizes: 7-2B11S/L, 7-2B22S/L, 7-4B18S/L, and 7-4B33S/L. The choice of size depends on the specific clinical application and anatomical considerations. For example, the length and diameter of the electrode may vary to accommodate different procedural needs, such as depth of tissue penetration or access routes. Consulting the manufacturer’s guidelines or your procedure’s requirements will help determine the appropriate size.
Is the ELRA electrode reusable, and if not, what are the implications for sterilization and cost?
No, the ELRA electrode is intended for single-use only and is supplied sterile. Since it is non-reusable, each procedure requires a new electrode, which helps ensure patient safety and reduces the risk of cross-contamination. This also means that cost considerations should account for the need to purchase a new electrode per use, rather than reprocessing or sterilizing for reuse.
How should the ELRA electrode be stored, and what precautions should be taken to maintain its sterility?
The ELRA electrode is supplied sterile, so it should be stored in its original packaging until ready for use. The packaging should remain unopened and protected from physical damage, moisture, or contamination. Once opened, the electrode must be used immediately to preserve sterility. Avoid exposing it to extreme temperatures or direct sunlight, as these could compromise its integrity or sterility.
What regulatory pathways has the ELRA electrode undergone, and who is responsible for its compliance?
The ELRA electrode has undergone FDA 510(k) clearance (classified as Class IIb, Special, Substantially Equivalent), as well as compliance with the EU’s Medical Device Directive (MDD) and Medical Device Regulation (MDR). STARmed Co., Ltd. is the manufacturer, while Emergo Europe B.V. (SRN: NL-AR-000000116) appears to have been involved in its regulatory authorization process. These pathways ensure the device meets safety and performance standards for its intended use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF ELRA Electrode - instrumed-surgical.com, PDF Electrode for electrosurgical device [ELRA Electrode] - STARmed America, ELRA™ Bipolar RFA Electrode Catheter - STARMED America
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233113 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | B-08809306762344 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K181758 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306762344 | Class IIb | Active |
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Manufacturer
- Manufacturer
- STARmed Co., Ltd.
- EUDAMED SRN
- KR-MF-000008605
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 359a2214-be7b-4582-a8d7-964a1bc0993f 85 fields · synced Sep 18, 2026
- EUDAMED 5c24ca45-589a-475d-94e1-517c3a4e1901 61 fields · synced May 19, 2026
- FDA UDI 92d2be9e-762d-40d4-94b7-30fab38f5699 36 fields · synced May 30, 2026
- FDA 510(k) K233113 1 fields · synced Jun 9, 2026