DeviceClearance

AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)— 510(k) K260255

Substantially Equivalent

Aventix Medical, Inc.

FDA 510(k) clearance K260255 for AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001), Substantially Equivalent on 2026-03-27. Applicant: Aventix Medical, Inc.. Device class: 2.

Summary

Aventix Medical's record covers two devices, the AVENTIX PFX System (PFX01) and the NOVOCLEAR Device (CLR001). Both are filed under GEI, electrosurgical cutting and coagulation devices and accessories.

Class II, 21 CFR 878.4400. The Ear, Nose, and Throat review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.

Aventix Medical filed from Laguna Hills, California. The decision came 58 calendar days after receipt (January 28 to March 27, 2026).

Clearance details

Applicant
Aventix Medical, Inc.
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
Laguna Hills, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GEI

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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.