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FDA 510(k)

RELiZORB

K-Number: K191379 · 2019-12-04

ApplicantAlcresta Therapeutics, Inc.
Decision Date2019-12-04
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 2019-12-04 under approval number K191379. 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 2019-12-04. It is manufactured by Alcresta Therapeutics, Inc.. The 510(k) number is K191379.

When was RELiZORB approved by the FDA?

RELiZORB received FDA 510(k) clearance on 2019-12-04, under approval number K191379.

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.

K161247Relizorb K163057Relizorb K232784RELiZORB® K231156Enzyme Packed Cartridge - RELiZORB K250499RELiZORB (100300/100301) K243284RELiZORB (100300/ 100301)

View all 7 devices →

Related Devices (Code: PLQ)

K161247RelizorbAlcresta Therapeutics, Inc. K163057RelizorbAlcresta 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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