Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Family of Steam Sterilizers B 28 series

K-Number: K151597 · 2016-03-04

ApplicantCefla S.C.
Decision Date2016-03-04
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Family of Steam Sterilizers B 28 series is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K151597. 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 Family of Steam Sterilizers B 28 series?

Family of Steam Sterilizers B 28 series is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Cefla S.C.. The 510(k) number is K151597.

When did Family of Steam Sterilizers B 28 series receive FDA 510(k) clearance?

Family of Steam Sterilizers B 28 series received FDA 510(k) clearance on 2016-03-04, under 510(k) number K151597.

Who is the listed applicant for Family of Steam Sterilizers B 28 series?

The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Family of Steam Sterilizers B 28 series?

The FDA product code for Family of Steam Sterilizers B 28 series is FLE.

Other records listing Cefla S.C. 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.

K260716NeowiseK252353myray ProXIma X6K230895CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,K231990Apex LocatorK223794hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSK213022CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED

View all 15 devices →

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 CorporationK260254Enbio PROEnbio Group AGK252307Getinge 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.

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.

↑