LYNX COBLATION Laryngeal Wand (72290254)— 510(k) K253680
Substantially EquivalentArthroCare Corporation
FDA 510(k) clearance K253680 for LYNX COBLATION Laryngeal Wand (72290254), Substantially Equivalent on 2026-03-25. Applicant: ArthroCare Corporation. Device class: 2.
Summary
ArthroCare's LYNX COBLATION Laryngeal Wand (72290254) is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record doesn't describe the wand beyond its name and that code name.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
ArthroCare filed from Austin, Texas. Review took 124 calendar days (November 21, 2025 to March 25, 2026).
Clearance details
- Applicant
- ArthroCare Corporation
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
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Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.