TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)— 510(k) K862436

Substantially Equivalent

Acutronic Medical Systems AG

FDA 510(k) clearance K862436 for TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN), Substantially Equivalent on 1986-11-03. Applicant: Acutronic Medical Systems AG.

Clearance details

Applicant: Acutronic Medical Systems AG
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1986-06-26
Decision date: 1986-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jona-Rapper Swril, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.