Manufacturer
ArthroCare CorporationLYNX COBLATION Laryngeal Wand (72290254)
Country / Region:United States (US)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
- K253680
- Device name
- LYNX COBLATION Laryngeal Wand (72290254)
- Company
- ArthroCare Corporation
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-11-21
- Decision date
- 2026-03-25
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryTissue Repair
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The LYNX™ COBLATION™ Laryngeal Wand is indicated for ablation, resection, and coagulation of soft tissues and hemostasis of blood vessels for otorhinolaryngology (ENT) procedures of the larynx and trachea.
Intended Use
The LYNX™ COBLATION™ Laryngeal Wand is indicated for ablation, resection and coagulation of soft tissues and hemostasis of blood vessels for otorhinolaryngology (ENT) surgical procedures of the larynx and trachea.
Device Description
The LYNX COBLATION Laryngeal Wand is a single-use, disposable, bipolar, radio frequency, electrosurgical device intended for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) procedures. The device is intended to work with Qualified Controllers (WEREWOLF COBLATION SYSTEM (WEREWOLF ENT and WEREWOLF +). The LYNX Wand consists of three integrated lines built into the handpiece that allow the wand to work as intended: An integrated suction line allows connection to suction source within the operating environment. An integrated saline tube set designed to be compatible with the WEREWOLF flow control module allows connection with saline source within the operating environment. An integrated cable compatible with the WEREWOLF controller. The device operates in Coblation (resection/ablation) and Coagulation (coagulation/hemostasis) modes by using their bipolar configuration to create energy field using a conductive irrigating solution.
Summary parsed at:2026-06-19 23:52:27 UTC