AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM— 510(k) K021929

Substantially Equivalent

Axya Medical, Inc.

FDA 510(k) clearance K021929 for AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM, Substantially Equivalent on 2002-09-10. Applicant: Axya Medical, Inc..

Clearance details

Applicant: Axya Medical, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2002-06-12
Decision date: 2002-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.