Cleared Traditional

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) (K250126) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250126 · Livsmed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
277d
Days
Class 2
Risk

K250126 is an FDA 510(k) clearance for the ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Livsmed, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on October 21, 2025 after a review of 277 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Livsmed, Inc. devices

Submission Details

510(k) Number K250126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2025
Decision Date October 21, 2025
Days to Decision 277 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 115d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 619
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K250126.
Voyant® Open Fusion Device (EB240/Open Fusion)
K252740 · Applied Medical Resources Corp. · Nov 2025
Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
K252412 · Applied Medical Resources Corporation · Oct 2025
PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
K250275 · Baylis Medical Technologies, Inc. · Oct 2025
Coolfase
K250852 · Asterasys Co., Ltd. · Oct 2025
InbellaMulti System
K252367 · Inbella Medical, Inc. · Oct 2025
Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US)
K250688 · Acotec Scientific Co., Ltd. · Oct 2025