Sturdy Autoclave Super Microm— 510(k) K231489

Name: FDA 510(k) clearance K231489
Creator: U.S. Food and Drug Administration
Published: 2023-06-21

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.. Device class: 2.

Clearance details

Applicant: Sturdy Industrial Co., Ltd.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
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 ↗

Recent devices under product code FLE

view all

K261055 — AMSCO 700 Steam Sterilizer2026-06-24
K260254 — Enbio PRO2026-02-26
K252307 — Getinge GSS67N Series Steam Sterilizer2026-01-22
K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer2025-12-30
K250164 — Cassette Autoclave (ACA5)2025-08-14

More clearances from Sturdy Industrial Co., Ltd.

view all

K181993 — STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)2019-11-01
K032596 — STURDY MANUAL RESUSCITATOR2004-08-05

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.