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FDA 510(k)

Enbio PRO

K-Number: K260254 · 2026-02-26

ApplicantEnbio Group AG
Decision Date2026-02-26
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Enbio PRO 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 2026-02-26 under 510(k) number K260254. 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 PRO?

Enbio PRO is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Enbio Group AG. The 510(k) number is K260254.

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

Enbio PRO received FDA 510(k) clearance on 2026-02-26, under 510(k) number K260254.

Who is the listed applicant for Enbio PRO?

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 PRO?

The FDA product code for Enbio PRO 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.

K213991Enbio SK210279Enbio S

Related Devices (Code: FLE)

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.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.K243801FRONT-LINE Field Sterilizer (FL135)Fort Defiance Industries, LLC

Official Source

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

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