Stryker RF Parallel Bipolar Adaptor Cable
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- N/A FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Device Name
- Bipolar Cables EUDAMEDBipolar Generator/Irrigator Interconnect Cable FDA UDIBipolar Foot Pedal Adapter Cable FDA UDI
- Model / Reference
- 6700-313-004 EUDAMEDFDA UDI6700-313-304 EUDAMEDFDA UDI08858250000640RV EUDAMED
- Description
- Bipolar Generator/Irrigator Interconnect Cable FDA UDIBipolar Foot Pedal Adapter Cable FDA UDI
Identifiers
- Catalog Number
- 6700-313-004 FDA UDI6700-313-304 FDA UDI
- Primary DI / UDI-DI
- 07613327303841 EUDAMEDFDA UDI07613327303858 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858250000640RV EUDAMED
- Direct Marketing DI
- 07613327303858 EUDAMED07613327303841 EUDAMED
- 510(k) Number
- K061660 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)FDA UDI
- EMDN Code
- Z12130580 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDL181003 ELECTROSURGERY CONNECTION CABLES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable 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
- Netherlands 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
No
Single Use
No
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
No
Manufacturing Date
No
The Stryker RF Parallel Bipolar Adaptor Cable is a medical device classified as a Radiofrequency Electrosurgical Adaptor Cable (Product Code: GEI). It is designed to facilitate the connection of bipolar electrosurgical instruments to radiofrequency generators, enabling precise tissue coagulation and cutting during surgical procedures. This adaptor cable ensures efficient energy transfer while maintaining safety standards for electrosurgical applications.
This device is supplied as a reusable component, intended for use in sterile surgical settings. It is regulated under the FDA 510(k) clearance and MDR requirements, with a clearance type classified as Traditional. The cable is part of the General, Plastic Surgery advisory committee category and is manufactured by Stryker Instruments. No specific MRI safety classification is stated, and storage conditions are not detailed in the provided data.
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 | K061660 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Instruments
Sources (5)
- FDA 510(k) K061660 24 fields · synced Sep 18, 2026
- FDA UDI eb8f8e22-c8bb-4bba-b52a-e412d1aa47fe 35 fields · synced May 30, 2026
- FDA UDI 841ff4fd-1cca-495c-8cc7-ae70ba0994a3 35 fields · synced May 30, 2026
- EUDAMED 4ac68372-a5c0-4d2e-af98-09d3e043fa59 61 fields · synced Jul 10, 2026
- EUDAMED a66bceb3-5721-4e43-bd1b-4923fe10bede 61 fields · synced Jul 13, 2026