A.C.L. GUIDE KIT— 510(k) K862564

Substantially Equivalent

Aspen Laboratories, Inc.

FDA 510(k) clearance K862564 for A.C.L. GUIDE KIT, Substantially Equivalent on 1986-08-18. Applicant: Aspen Laboratories, Inc..

Clearance details

Applicant: Aspen Laboratories, Inc.
Product code: Code FZX
Advisory panel: General, Plastic Surgery
Date received: 1986-07-03
Decision date: 1986-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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Adverse events under product code FZX

product code FZX

Injury: 797
Malfunction: 3,815
Total: 4,612

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.