SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01— 510(k) K990568

Substantially Equivalent

Synergetics, Inc.

FDA 510(k) clearance K990568 for SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01, Substantially Equivalent on 1999-05-14. Applicant: Synergetics, Inc..

Clearance details

Applicant: Synergetics, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1999-02-23
Decision date: 1999-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Charles, MO, 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.