510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884379Substantially Equivalent

Maglinte Enteroclysis Catheter

Lafayette Pharmacal, Inc., Lafayette IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884379 is the FDA 510(k) clearance record for MAGLINTE ENTEROCLYSIS CATHETER, a class II device, cleared for Lafayette Pharmacal, Inc. on under FDA product code FGD (Catheter, Retention, Barium Enema With Bag). FDA records list 4 510(k) clearances for Lafayette Pharmacal, Inc., from to . As of , FDA records show no recalls naming K884379.

Clearance record

Decision date
Received
(133 days to decision)
Product code
FGD Catheter, Retention, Barium Enema With Bag
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Lafayette Pharmacal, Inc. 522 N. Earl Ave., Lafayette IN
Third party review
No

Clearances, product code FGD

Trailing 12 months

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

FDA records show no clearances under product code FGD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FGD, 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