Medical Device Manufacturer · US , Newton , MA

Alcresta Therapeutics, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2016

Recent clearances: RELiZORB (100300/100301), RELiZORB (100300/ 100301), RELiZORB®

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Alcresta Therapeutics, Inc. Gastroenterology & Urology ✕

7 devices

1-7 of 7

Cleared Apr 17, 2025

RELiZORB (100300/100301)

Gastroenterology & Urology · 56d

Cleared Jan 15, 2025

RELiZORB (100300/ 100301)

Gastroenterology & Urology · 90d

Cleared Dec 21, 2023

Gastroenterology & Urology · 101d

Cleared Aug 30, 2023

Enzyme Packed Cartridge - RELiZORB

Gastroenterology & Urology · 128d

Cleared Dec 04, 2019

Gastroenterology & Urology · 195d

Cleared Jul 12, 2017

Gastroenterology & Urology · 253d

Cleared Jun 30, 2016

Gastroenterology & Urology · 58d