FDA.report

510(k) K253680

Device
LYNX COBLATION Laryngeal Wand (72290254)
Applicant
ArthroCare Corporation
510(k) number
K253680
Product code
GEI
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-25
Date received
2025-11-21
Regulation
878.4400
Classification name
Electrosurgical, Cutting & Coagulation & Accessories
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Srividya Pothana
Address
7000 W. William Cannon Dr. Austin TX US 78735 78735

FDA Registration Numbers

Source Documents

510(k) summary PDF

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