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FDA 510(k)

RELiZORB (100300/ 100301)

K-Number: K243284 · 2025-01-15

ApplicantAlcresta Therapeutics, Inc.
Decision Date2025-01-15
Product CodePLQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RELiZORB (100300/ 100301) 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 2025-01-15 under 510(k) number K243284. 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 (100300/ 100301)?

RELiZORB (100300/ 100301) is a medical device that received FDA 510(k) clearance on 2025-01-15. The listed applicant is Alcresta Therapeutics, Inc.. The 510(k) number is K243284.

When did RELiZORB (100300/ 100301) receive FDA 510(k) clearance?

RELiZORB (100300/ 100301) received FDA 510(k) clearance on 2025-01-15, under 510(k) number K243284.

Who is the listed applicant for RELiZORB (100300/ 100301)?

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 (100300/ 100301)?

The FDA product code for RELiZORB (100300/ 100301) 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.

K250499RELiZORB (100300/100301)K232784RELiZORB®K231156Enzyme Packed Cartridge - RELiZORBK191379RELiZORBK163057RelizorbK161247Relizorb

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.

K250499RELiZORB (100300/100301)Alcresta Therapeutics, Inc.K232784RELiZORB®Alcresta Therapeutics, Inc.K231156Enzyme Packed Cartridge - RELiZORBAlcresta Therapeutics, Inc.K191379RELiZORBAlcresta Therapeutics, Inc.K163057RelizorbAlcresta Therapeutics, Inc.K161247RelizorbAlcresta Therapeutics, Inc.

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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