Sturdy Autoclave Super Microm— 510(k) K231489

Substantially Equivalent

Sturdy Industrial Co., Ltd.

FDA 510(k) clearance K231489 for Sturdy Autoclave Super Microm, Substantially Equivalent on 2023-06-21. Applicant: Sturdy Industrial Co., Ltd..

Clearance details

Applicant: Sturdy Industrial Co., Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2023-05-23
Decision date: 2023-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: New Taipei City, TW

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.