TruVision Single-Use 1.9mm Arthroscopy System— 510(k) K260156

Name: FDA 510(k) clearance K260156
Creator: U.S. Food and Drug Administration
Published: 2026-10-09

Substantially Equivalent

Nexus CMF, LLC

FDA 510(k) clearance K260156 for TruVision Single-Use 1.9mm Arthroscopy System, Substantially Equivalent on 2026-10-09. Applicant: Nexus CMF, LLC. Device class: 2.

Summary

Nexus CMF's TruVision Single-Use 1.9mm Arthroscopy System is filed under HRX, arthroscopes. The name gives a 1.9 mm size and a single-use design. The record doesn't list the system's components or which joints it's meant for.

Class II, 21 CFR 888.1100. The Orthopedic panel reviewed it as a Traditional 510(k).

The applicant is based in Salt Lake City, Utah. Review took 262 days (January 20 to October 9, 2026).

Clearance details

Applicant: Nexus CMF, LLC
Product code: Product code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2026-01-20
Decision date: 2026-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.