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

Name: FDA 510(k) clearance K021929
Creator: U.S. Food and Drug Administration
Published: 2002-09-10

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.. Device class: Unclassified.

Clearance details

Applicant: Axya Medical, Inc.
Product code: Code LFL
Device class: Unclassified
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 ↗

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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.