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FDA 510(k)

Enzyme Packed Cartridge - RELiZORB

K-Number: K231156 · 2023-08-30

Decision Date2023-08-30
Product CodePLQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Enzyme Packed Cartridge - 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 2023-08-30 under 510(k) 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. The listed applicant is Alcresta Therapeutics, Inc.. The 510(k) number is K231156.

When did Enzyme Packed Cartridge - RELiZORB receive FDA 510(k) clearance?

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

Who is the listed applicant for Enzyme Packed Cartridge - 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 Enzyme Packed Cartridge - RELiZORB?

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

Related Clinical Trials

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.

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.