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FDA 510(k)

Family of Steam sterilizers B17 B22 Series

K-Number: K161848 · 2017-02-23

ApplicantCefla S.C.
Decision Date2017-02-23
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Family of Steam sterilizers B17 B22 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 2017-02-23 under 510(k) number K161848. 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 B17 B22 Series?

Family of Steam sterilizers B17 B22 Series is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Cefla S.C.. The 510(k) number is K161848.

When did Family of Steam sterilizers B17 B22 Series receive FDA 510(k) clearance?

Family of Steam sterilizers B17 B22 Series received FDA 510(k) clearance on 2017-02-23, under 510(k) number K161848.

Who is the listed applicant for Family of Steam sterilizers B17 B22 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 B17 B22 Series?

The FDA product code for Family of Steam sterilizers B17 B22 Series is FLE.

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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.

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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.

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