ArtiSential Laparoscopic Instruments-Electrodes
FDA 510(k) K203580 · Livsmed, Inc.
510(k) numberK203580
Submission
- Device name
- ArtiSential Laparoscopic Instruments-Electrodes
- Applicant
- Livsmed, Inc.
Seongnam-Si, KR - Received
- December 7, 2020
- Decision date
- April 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K230498 | ArtiSential Laparoscopic Instruments-ElectrodesGEI · Traditional | 06/05/2023SE |
| K230539 | ArtiSential Laparoscopic Instruments-ElectrodesGEI · Traditional | 04/27/2023SE |
| K230499 | ArtiSential Laparoscopic Instruments-ElectrodesGEI · Traditional | 04/26/2023SE |
| K220384 | ArtiSential Laparoscopic Instruments-ElectrodesGEI · Special | 02/24/2022SE |
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Questions and answers
When was ArtiSential Laparoscopic Instruments-Electrodes cleared by the FDA?
ArtiSential Laparoscopic Instruments-Electrodes (K203580) received a 510(k) decision of Substantially Equivalent on April 30, 2021, 144 days after the submission was received.
What is the product code of K203580?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.