WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER— 510(k) K020673

Substantially Equivalent

Wave Form Mfg., Inc.

FDA 510(k) clearance K020673 for WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER, Substantially Equivalent on 2002-05-30. Applicant: Wave Form Mfg., Inc..

Clearance details

Applicant: Wave Form Mfg., Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2002-03-01
Decision date: 2002-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Panama City Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.