510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163057Substantially Equivalent

Relizorb

Alcresta Therapeutics, Inc., Newton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163057 is the FDA 510(k) clearance record for Relizorb, a class II device, cleared for Alcresta Therapeutics, Inc. on under FDA product code PLQ (Enzyme Packed Cartridge). FDA's definition for product code PLQ reads: "Hydrolyze fats in enteral formula". FDA records list 7 510(k) clearances for Alcresta Therapeutics, Inc., from to . As of , FDA records show no recalls naming K163057.

Clearance record

Decision date
Received
(253 days to decision)
Product code
PLQ Enzyme Packed Cartridge
Regulation
21 CFR 876.5985
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Alcresta Therapeutics, Inc. One Newton Executive Park, Newton MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLQ

Trailing 12 months

FDA records hold no clearances under product code PLQ in the trailing twelve months.

FDA records show no clearances under product code PLQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PLQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260