Manufacturer
Livsmed, Inc.ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250126
- Device name
- ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
- Company
- Livsmed, Inc.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-01-17
- Decision date
- 2025-10-21
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- Surgery
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use only with the ArtiSeal Generator in minimally invasive or open surgical procedures where ligation (sealing) and division (cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery.
Intended Use
ArtiSeal Vessel Sealing System - ArtiSeal Instruments are a bipolar electrosurgical instrument intended for use only with the ArtiSeal Generator in minimally invasive or open surgical procedures where ligation (sealing) and division (Cutting) of vessels and tissue bundles is desired. ArtiSeal Vessel Sealing System - ArtiSeal Instruments can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery.
Device Description
The ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is a sterile, single-use, invasive instrument which is used with electrosurgical generator (ArtiSeal Generator), intended to be used during laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels and tissue bundles is desired. When activating the sealing button of ArtiSeal Vessel Sealing System-ArtiSeal instruments, the ArtiSeal Generator applies radiofrequency (RF) energy to the electrode portion of the jaw. Heat is generated from the electrode for ligation. During surgical procedures, the user operates the grip lever to open and close the jaw. Furthermore, the jaw can be bent up, down, left, and right within a range of up to ±90° or more by adjusting the grip accordingly. The jaw also provides 360° articulation (rotation) by turning the grip.
Summary parsed at:2026-06-20 17:46:49 UTC
Predicate devices
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Cited as predicate
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