FlexTip Bipolar Electrodes Single-Use (AR-S9805-0028), FlexTip Bipolar Electrodes Single-Use (AR-S9805-0035)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Sutter FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- Bipolar Electrodes single-use EUDAMEDBipolar electrode Single-Use Binner nasal concha incl. cable 3m for Curis® FDA UDI
- Model / Reference
- 704462 EUDAMEDFDA UDI704499 EUDAMED
- Description
- Bipolar electrode Single-Use Binner nasal concha incl. cable 3m for Curis® FDA UDI
Identifiers
- Catalog Number
- 704462 FDA UDI
- Primary DI / UDI-DI
- ESUM7044620 EUDAMEDFDA UDIESUM7044990 EUDAMED
- Basic UDI-DI
- ++ESUMTD18704400FV EUDAMED
- 510(k) Number
- K233425 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb 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
- Germany 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
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 FlexTip Bipolar Electrodes Single-Use (AR-S9805-0028 and AR-S9805-0035) are disposable bipolar electrodes designed for use in surgical procedures. These electrodes facilitate precise tissue coagulation and cutting by delivering controlled electrical energy, aiding in procedures within the general and plastic surgery domains.
Intended for single-use only, these electrodes are supplied sterile and are classified under product code GEI. They are regulated under the FDA’s 510(k) pathway, with a clearance determination of Substantially Equivalent, and comply with the Medical Device Regulation (MDR). Storage and handling must adhere to sterile medical device protocols to ensure integrity prior to use.
Frequently asked questions
What surgical specialties are these electrodes primarily intended for based on their regulatory classification?
The FlexTip Bipolar Electrodes (AR-S9805-0028 and AR-S9805-0035) are classified under product code GEI and reviewed by the Surgical Devices (SU) Advisory Committee, indicating their primary intended use is in general and plastic surgery procedures. This classification aligns with their design for precise tissue coagulation and cutting during surgical interventions.
Are these electrodes reusable, or must they be discarded after a single use?
These electrodes are explicitly labeled for single-use only, meaning they must be discarded after one surgical procedure to maintain sterility and performance. The manufacturer emphasizes this in their description to ensure proper infection control and device efficacy.
How should I store these electrodes to preserve their sterility before use?
Since they are supplied sterile, storage must follow standard sterile medical device protocols. This includes keeping them in their original packaging, away from direct sunlight or extreme temperatures, and ensuring the seals remain intact until the time of use to prevent contamination.
What regulatory pathways have these electrodes undergone, and what does that mean for their use?
The electrodes have been cleared via the FDA’s 510(k) pathway with a determination of Substantially Equivalent (SESE) to a predicate device, and they comply with the Medical Device Regulation (MDR) in the EU. This means they meet established safety and performance standards for their intended surgical applications in coagulation and cutting, ensuring they can be legally marketed and used in the U.S. and EU markets.
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 | K233425 | Class II | Active |
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Manufacturer
- Manufacturer
- Sutter Medizintechnik GmbH
Sources (4)
- FDA 510(k) K233425 24 fields · synced Sep 18, 2026
- FDA UDI e967f54a-07a4-4c6e-9647-3aad8dc7a3fb 35 fields · synced May 30, 2026
- EUDAMED 31888008-1eb9-495d-9ba6-c75b24a4a896 61 fields · synced Jul 18, 2026
- EUDAMED c1c43890-34c1-4adb-af0a-fc0f44e9f22f 61 fields · synced Jul 30, 2026