FDA 510(k)

Saniclave 250

K-Number: K180272 · 2018-07-26

Decision Date2018-07-26

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Saniclave 250 is the device name listed in this FDA 510(k) record. The listed applicant is Revolutionary Science. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K180272. 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 Saniclave 250?

Saniclave 250 is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Revolutionary Science. The 510(k) number is K180272.

When did Saniclave 250 receive FDA 510(k) clearance?

Saniclave 250 received FDA 510(k) clearance on 2018-07-26, under 510(k) number K180272.

Who is the listed applicant for Saniclave 250?

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

What is the FDA product code for Saniclave 250?

The FDA product code for Saniclave 250 is FLE.

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

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