Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS— 510(k) K222608

Substantially Equivalent

Tuttnauer , Ltd.

FDA 510(k) clearance K222608 for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS, Substantially Equivalent on 2022-12-16. Applicant: Tuttnauer , Ltd..

Clearance details

Applicant: Tuttnauer , Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2022-08-29
Decision date: 2022-12-16
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.