FLOW FLEXTEND Wand (72290039)— 510(k) K254122
Substantially EquivalentArthroCare Corporation
FDA 510(k) clearance K254122 for FLOW FLEXTEND Wand (72290039), Substantially Equivalent on 2026-03-30. Applicant: ArthroCare Corporation. Device class: 2.
Summary
ArthroCare's FLOW FLEXTEND Wand (72290039) 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. It was a Traditional 510(k), and General and Plastic Surgery is both the classification panel and the review panel.
ArthroCare filed from Austin, Texas. The decision came 101 calendar days after FDA received it (December 19, 2025 to March 30, 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.