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FDA 510(k)

Relizorb

K-Number: K161247 · 2016-06-30

ApplicantAlcresta Therapeutics, Inc.
Decision Date2016-06-30
Product CodePLQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Relizorb is a medical device manufactured by Alcresta Therapeutics, Inc.. It received FDA 510(k) clearance on 2016-06-30 under approval number K161247. 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 2016-06-30. It is manufactured by Alcresta Therapeutics, Inc.. The 510(k) number is K161247.

When was Relizorb approved by the FDA?

Relizorb received FDA 510(k) clearance on 2016-06-30, under approval number K161247.

What company makes Relizorb?

Relizorb is manufactured by Alcresta Therapeutics, Inc..

What is the FDA product code for Relizorb?

The FDA product code for Relizorb is PLQ.

Other Devices by Alcresta Therapeutics, Inc.

K163057Relizorb K191379RELiZORB K232784RELiZORB® K231156Enzyme Packed Cartridge - RELiZORB K250499RELiZORB (100300/100301) K243284RELiZORB (100300/ 100301)

View all 7 devices →

Related Devices (Code: PLQ)

K163057RelizorbAlcresta Therapeutics, Inc. K191379RELiZORBAlcresta Therapeutics, Inc. K232784RELiZORB®Alcresta Therapeutics, Inc. K231156Enzyme Packed Cartridge - RELiZORBAlcresta 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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