Electrosurgical accessory
FDA 510(k) K210394 · Dornier Medtech America, Inc.
510(k) numberK210394
Submission
- Device name
- Electrosurgical accessory
- Applicant
- Dornier Medtech America, Inc.
Kennesaw, GA, US - Received
- February 10, 2021
- Decision date
- May 19, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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| K171965 | Resection Electrodes with HF cableFAS · Traditional | Olympus Winter & Ibe GmbH | 09/28/2017SE |
| K163090 | Plasma Edge SystemFAS · Traditional | Chirurgie Innovation | 05/23/2017SE |
| K151976 | Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeFAS · Traditional | Omnitech Systems, Inc. | 06/27/2016SE |
| K152092 | Resection ElectrodesFAS · Traditional | Olympus Winter & Ibe GmbH | 10/26/2015SE |
| K120567 | Gyrus Amci PK Button ElectrodeFAS · Traditional | Gyrus Acmi, Inc. | 06/20/2012SE |
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| K221903 | Delta III ProLNS · Traditional | 02/22/2023SE |
| K213252 | Dornier ThulioGEX · Traditional | 07/27/2022SE |
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| K201815 | Dornier MAGELLAN Ureteral Access SheathFED · Traditional | 11/20/2020SE |
| K201074 | Delta III LithotripterLNS · Traditional | 09/03/2020SE |
| K190612 | EQUINOX Balloon Dilatation CatheterEZN · Traditional | 12/06/2019SE |
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Questions and answers
When was Electrosurgical accessory cleared by the FDA?
Electrosurgical accessory (K210394) received a 510(k) decision of Substantially Equivalent on May 19, 2021, 98 days after the submission was received.
What is the product code of K210394?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.