LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS— 510(k) K864384

Substantially Equivalent

Luxtec Corp.

FDA 510(k) clearance K864384 for LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS, Substantially Equivalent on 1986-11-19. Applicant: Luxtec Corp..

Clearance details

Applicant: Luxtec Corp.
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 1986-11-05
Decision date: 1986-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturbridge, MA, US

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Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.