Cleared Traditional

Enbio S

K210279 · Enbio Group AG · General Hospital

Oct 2021

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K210279 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 October 29, 2021, 270 days after receiving the submission on February 1, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6880.

Submission Details

510(k) Number	K210279 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2021
Decision Date	October 29, 2021
Days to Decision	270 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF