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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 a medical device manufactured by Alcresta Therapeutics, Inc.. It received FDA 510(k) clearance on 2025-01-15 under approval 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. It is manufactured by Alcresta Therapeutics, Inc.. The 510(k) number is K243284.

When was RELiZORB (100300/ 100301) approved by the FDA?

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

What company makes RELiZORB (100300/ 100301)?

RELiZORB (100300/ 100301) is manufactured by Alcresta Therapeutics, Inc..

What is the FDA product code for RELiZORB (100300/ 100301)?

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

Other Devices by Alcresta Therapeutics, Inc.

K161247Relizorb K163057Relizorb K191379RELiZORB K232784RELiZORB® K231156Enzyme Packed Cartridge - RELiZORB K250499RELiZORB (100300/100301)

View all 7 devices →

Related Devices (Code: PLQ)

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