SKIN STAT II SKIN STAPLING MEDICAL DEVICE— 510(k) K844838

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K844838 for SKIN STAT II SKIN STAPLING MEDICAL DEVICE, Substantially Equivalent on 1985-01-23. Applicant: Edward Weck, Inc..

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code GDT
Advisory panel: General, Plastic Surgery
Date received: 1984-12-12
Decision date: 1985-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pa, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GDT

product code GDT

Malfunction: 752
Total: 752

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.