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FDA 510(k)

RELiZORB®

K-Number: K232784 · 2023-12-21

Decision Date2023-12-21
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 2023-12-21 under 510(k) number K232784. 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 2023-12-21. The listed applicant is Alcresta Therapeutics, Inc.. The 510(k) number is K232784.

When did RELiZORB® receive FDA 510(k) clearance?

RELiZORB® received FDA 510(k) clearance on 2023-12-21, under 510(k) number K232784.

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.