MEDISIZE GOLD— 510(k) K052615

Substantially Equivalent

Medisize BV

FDA 510(k) clearance K052615 for MEDISIZE GOLD, Substantially Equivalent on 2005-12-09. Applicant: Medisize BV.

Clearance details

Applicant: Medisize BV
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2005-09-23
Decision date: 2005-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillegom, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.