510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190923Substantially Equivalent

Salem Sump Dual Lumen Stomach Tube with ENFit Connection

Cardinalhealth, Mansfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190923 is the FDA 510(k) clearance record for Salem Sump Dual Lumen Stomach Tube with ENFit Connection, a class II device, cleared for Cardinalhealth on under FDA product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors). FDA's definition for product code PIF reads: "To facilitate enteral specific connections". FDA records list 32 510(k) clearances for Cardinalhealth, from to . As of , FDA records show one recall naming K190923.

Clearance record

Decision date
Received
(212 days to decision)
Product code
PIF Gastrointestinal Tubes With Enteral Specific Connectors
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cardinalhealth 777 W. St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PIF

Trailing 12 months
3 clearances under product code PIF in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PIF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260