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FDA 510(k)

Enzyme Packed Cartridge - RELiZORB

K-Number: K231156 · 2023-08-30

ApplicantAlcresta Therapeutics, Inc.
Decision Date2023-08-30
Product CodePLQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Enzyme Packed Cartridge - RELiZORB is a medical device manufactured by Alcresta Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-08-30 under approval number K231156. 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 Enzyme Packed Cartridge - RELiZORB?

Enzyme Packed Cartridge - RELiZORB is a medical device that received FDA 510(k) clearance on 2023-08-30. It is manufactured by Alcresta Therapeutics, Inc.. The 510(k) number is K231156.

When was Enzyme Packed Cartridge - RELiZORB approved by the FDA?

Enzyme Packed Cartridge - RELiZORB received FDA 510(k) clearance on 2023-08-30, under approval number K231156.

What company makes Enzyme Packed Cartridge - RELiZORB?

Enzyme Packed Cartridge - RELiZORB is manufactured by Alcresta Therapeutics, Inc..

What is the FDA product code for Enzyme Packed Cartridge - RELiZORB?

The FDA product code for Enzyme Packed Cartridge - RELiZORB is PLQ.

Related Clinical Trials

NCT06691893 Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients RECRUITING NCT07583342 Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis ENROLLING_BY_INVITATION

Other Devices by Alcresta Therapeutics, Inc.

K161247Relizorb K163057Relizorb K191379RELiZORB K232784RELiZORB® K250499RELiZORB (100300/100301) K243284RELiZORB (100300/ 100301)

View all 7 devices →

Related Devices (Code: PLQ)

K161247RelizorbAlcresta Therapeutics, Inc. K163057RelizorbAlcresta Therapeutics, Inc. K191379RELiZORBAlcresta Therapeutics, Inc. K232784RELiZORB®Alcresta Therapeutics, Inc. K250499RELiZORB (100300/100301)Alcresta Therapeutics, Inc. K243284RELiZORB (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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