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FDA 510(k)

Relizorb

K-Number: K163057 · 2017-07-12

Decision Date2017-07-12
Product CodePLQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Relizorb is the device name listed in this FDA 510(k) record. The listed applicant is Alcresta Therapeutics, Inc.. It received FDA 510(k) clearance on 2017-07-12 under 510(k) number K163057. The device is classified under product code PLQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Relizorb?

Relizorb is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is Alcresta Therapeutics, Inc.. The 510(k) number is K163057.

When did Relizorb receive FDA 510(k) clearance?

Relizorb received FDA 510(k) clearance on 2017-07-12, under 510(k) number K163057.

Who is the listed applicant for Relizorb?

The FDA 510(k) record lists Alcresta Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Relizorb?

The FDA product code for Relizorb is PLQ.

Other records listing Alcresta Therapeutics, Inc. 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.

View all 7 devices →

Related Devices (Code: PLQ)

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.

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.