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FDA 510(k)

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

K-Number: K163144 · 2017-04-07

ApplicantGke-GmbH
Decision Date2017-04-07
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) is the device name listed in this FDA 510(k) record. The listed applicant is Gke-GmbH. It received FDA 510(k) clearance on 2017-04-07 under 510(k) number K163144. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)?

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) is a medical device that received FDA 510(k) clearance on 2017-04-07. The listed applicant is Gke-GmbH. The 510(k) number is K163144.

When did gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) receive FDA 510(k) clearance?

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) received FDA 510(k) clearance on 2017-04-07, under 510(k) number K163144.

Who is the listed applicant for gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)?

The FDA 510(k) record lists Gke-GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)?

The FDA product code for gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) is FRC.

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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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