FDA 510(k)

WillCeph

K-Number: K172168 · 2018-03-21

Decision Date2018-03-21

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

WillCeph is the device name listed in this FDA 510(k) record. The listed applicant is Hdx Will Corp.. It received FDA 510(k) clearance on 2018-03-21 under 510(k) number K172168. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WillCeph?

WillCeph is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Hdx Will Corp.. The 510(k) number is K172168.

When did WillCeph receive FDA 510(k) clearance?

WillCeph received FDA 510(k) clearance on 2018-03-21, under 510(k) number K172168.

Who is the listed applicant for WillCeph?

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

What is the FDA product code for WillCeph?

The FDA product code for WillCeph is LLZ.

Other records listing Hdx Will Corp. 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.

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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.