KAPS POSITIONING ARM— 510(k) K935381

Substantially Equivalent

Andronic Devices, Ltd.

FDA 510(k) clearance K935381 for KAPS POSITIONING ARM, Substantially Equivalent on 1994-04-15. Applicant: Andronic Devices, Ltd..

Clearance details

Applicant: Andronic Devices, Ltd.
Product code: Code FWZ
Advisory panel: General, Plastic Surgery
Date received: 1993-11-08
Decision date: 1994-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond,B.C. Canada, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.