AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM— 510(k) K092723

Substantially Equivalent

Skeletal Dynamics, LLC

FDA 510(k) clearance K092723 for AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM, Substantially Equivalent on 2010-10-04. Applicant: Skeletal Dynamics, LLC.

Clearance details

Applicant: Skeletal Dynamics, LLC
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2009-09-04
Decision date: 2010-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

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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.