Soniquence Reusable Bipolar Cable
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Bipolar Cable EUDAMEDFDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- Bipolar Cable EUDAMEDBipolar Cable, Sterile/Disposable FDA UDI
- Model / Reference
- SIEC-DJX/1 EUDAMEDFDA UDISIEC-DJX EUDAMED
- Description
- Bipolar Cable, Sterile/Disposable FDA UDI
Identifiers
- Catalog Number
- SIEC-DJX/1 FDA UDI
- Primary DI / UDI-DI
- 00810026181757 EUDAMEDFDA UDI
- Basic UDI-DI
- 0081002618SIEC-DJX29 EUDAMED
- FDA Product Code
- GEI FDA 510(k)FDA UDI
- EMDN Code
- K02010203 ELECTROSURGERY CONNECTION CABLES, SINGLE-USE EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
No
The Soniquence Reusable Bipolar Cable is a reusable medical device classified under the nomenclature category GEI (General, Plastic Surgery). It is designed as a bipolar electrode cable used in electrosurgical procedures, facilitating precise tissue coagulation and cutting through controlled electrical energy delivery.
This device is intended for reusable clinical use in operating rooms and surgical settings. It is supplied sterile upon first use and must be cleaned, disinfected, and sterilized between procedures as per manufacturer guidelines. The cable is compatible with MRI environments and is authorised under FDA 510K clearance (K211946) and MDR compliance. Storage requires adherence to sterile processing protocols to ensure safety and functionality for repeated use.
Frequently asked questions
What types of surgical procedures is the Soniquence Reusable Bipolar Cable designed for, and how does it work?
The Soniquence Reusable Bipolar Cable is designed for use in electrosurgical procedures within operating rooms and surgical settings, specifically in plastic surgery applications. It delivers controlled electrical energy to facilitate precise tissue coagulation and cutting, which helps surgeons achieve hemostasis and tissue separation during procedures like excisions, reconstructions, or other plastic surgery interventions.
Is the cable single-use or reusable, and what cleaning and sterilization steps are required?
The Soniquence Reusable Bipolar Cable is intended for reusable clinical use and must be cleaned, disinfected, and sterilized between procedures to maintain safety and functionality. The manufacturer provides specific guidelines for reprocessing, ensuring compliance with sterile processing protocols to prepare it for repeated use in MRI-compatible environments.
Can this cable be used in MRI environments, and what regulatory approvals does it hold?
Yes, the Soniquence Reusable Bipolar Cable is compatible with MRI environments, as explicitly stated in its design specifications. It holds FDA 510(k) clearance (K211946) under a Special 510(k) pathway, demonstrating it is substantially equivalent to a predicate device, and it also complies with MDR (Medical Device Regulation) requirements for European markets.
How is the cable supplied, and what storage precautions should be taken?
The cable is supplied sterile upon first use, meaning it is ready for immediate clinical application without additional sterilization before its first procedure. After use, it must be reprocessed as per manufacturer guidelines. Storage requires adherence to sterile processing protocols to ensure the cable remains safe and functional for repeated use, preventing contamination or damage.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K211946 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Soniquence, LLC
Sources (3)
- FDA 510(k) K211946 24 fields · synced Sep 18, 2026
- FDA UDI 47303897-f5ab-4396-96c0-99e878cdffd2 35 fields · synced May 30, 2026
- EUDAMED 5b78ace5-6bbf-4405-9dee-f2bf05ffa391 61 fields · synced Jul 10, 2026