Cleared Traditional

Enbio PRO

K260254 · Enbio Group AG · General Hospital

Feb 2026

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K260254 is an FDA 510(k) clearance for the Enbio PRO, a Sterilizer, Steam (Class II — Special Controls, product code FLE), submitted by Enbio Group AG (Oensingen, CH). The FDA issued a Cleared decision on February 26, 2026, 30 days after receiving the submission on January 27, 2026. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K260254 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2026
Decision Date	February 26, 2026
Days to Decision	30 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF