FDA 510(k)

Enbio S

K-Number: K210279 · 2021-10-29

Decision Date2021-10-29

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Enbio S is the device name listed in this FDA 510(k) record. The listed applicant is Enbio Group AG. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K210279. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enbio S?

Enbio S is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Enbio Group AG. The 510(k) number is K210279.

When did Enbio S receive FDA 510(k) clearance?

Enbio S received FDA 510(k) clearance on 2021-10-29, under 510(k) number K210279.

Who is the listed applicant for Enbio S?

The FDA 510(k) record lists Enbio Group AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enbio S?

The FDA product code for Enbio S is FLE.

Other records listing Enbio Group AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260254Enbio PRO K213991Enbio S

Related Devices (Code: FLE)

K261055AMSCO 700 Steam SterilizerSTERIS Corporation K260254Enbio PROEnbio Group AG K252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare K250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.