FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ArtiSential Laparoscopic Instruments-Electrodes
K Number: K230498
·
Decision Jun 5, 2023
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
12
Review Days
101
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Basic Information
- Device Name
- ArtiSential Laparoscopic Instruments-Electrodes
- K Number
- K230498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Livsmed, Inc.
- Date Received
- February 24, 2023
- Decision Date
- June 5, 2023
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Livsmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250126 | ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) | Oct 21, 2025 | Substantially Equivalent |
| K241138 | ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator | Nov 15, 2024 | Substantially Equivalent |
| K240657 | ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L- | Jun 6, 2024 | Substantially Equivalent |
| K230539 | ArtiSential Laparoscopic Instruments-Electrodes | Apr 27, 2023 | Substantially Equivalent |
| K230499 | ArtiSential Laparoscopic Instruments-Electrodes | Apr 26, 2023 | Substantially Equivalent |
| K220384 | ArtiSential Laparoscopic Instruments-Electrodes | Feb 24, 2022 | Substantially Equivalent |
| K212500 | ArtiSential Trocar | Dec 3, 2021 | Substantially Equivalent |
| K203580 | ArtiSential Laparoscopic Instruments-Electrodes | Apr 30, 2021 | Substantially Equivalent |
| K200875 | ArtiSential Laparoscopic Instruments - Electrodes | Jun 17, 2020 | Substantially Equivalent |
| K200501 | ArtiSential Laparoscopic Instrument-Electrodes | May 11, 2020 | Substantially Equivalent |