FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ArtiSential Trocar
K Number: K212500
·
Decision Dec 3, 2021
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
12
Review Days
116
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Basic Information
- Device Name
- ArtiSential Trocar
- K Number
- K212500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Livsmed, Inc.
- Date Received
- August 9, 2021
- Decision Date
- December 3, 2021
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
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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 |
| K230498 | ArtiSential Laparoscopic Instruments-Electrodes | Jun 5, 2023 | 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 |
| 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 |