ADVANCIS ACTIVON TUBE— 510(k) K101114

Substantially Equivalent

Advancis Medical

FDA 510(k) clearance K101114 for ADVANCIS ACTIVON TUBE, Substantially Equivalent on 2011-07-26. Applicant: Advancis Medical.

Clearance details

Applicant: Advancis Medical
Product code: Code FRO
Advisory panel: Unknown
Date received: 2010-04-21
Decision date: 2011-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirby In Ashfield, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.