510(k) K800367— MICRESURGICAL TRAY, SM.,MED., & LG.

Substantially Equivalent

Edward Weck, Inc.

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code FSM
Advisory panel: General, Plastic Surgery
Date received: 1980-02-20
Decision date: 1980-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.