Cleared Special

Enbio S

K213991 · Enbio Group AG · General Hospital

Feb 2022

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K213991 is an FDA 510(k) clearance for the Enbio S, 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 22, 2022, 63 days after receiving the submission on December 21, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K213991 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2021
Decision Date	February 22, 2022
Days to Decision	63 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF