Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120— 510(k) K221227

Substantially Equivalent

Tuttnauer , Ltd.

FDA 510(k) clearance K221227 for Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120, Substantially Equivalent on 2022-09-20. Applicant: Tuttnauer , Ltd..

Clearance details

Applicant: Tuttnauer , Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2022-04-28
Decision date: 2022-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beit-Shemesh, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.