RELiZORB (100300/100301)— 510(k) K250499

Name: FDA 510(k) clearance K250499
Creator: U.S. Food and Drug Administration
Published: 2025-04-17

Substantially Equivalent

Alcresta Therapeutics, Inc.

FDA 510(k) clearance K250499 for RELiZORB (100300/100301), Substantially Equivalent on 2025-04-17. Applicant: Alcresta Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Alcresta Therapeutics, Inc.
Product code: Code PLQ
Device class: Class 2
Regulation: 21 CFR 876.5985
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-20
Decision date: 2025-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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