510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142297Substantially Equivalent

Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set

Xeridiem (Formerly Mri), Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142297 is the FDA 510(k) clearance record for Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set, a class II device, cleared for Xeridiem (Formerly Mri) 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 2 510(k) clearances for Xeridiem (Formerly Mri). As of , FDA records show 104 recalls naming K142297.

Clearance record

Decision date
Received
(143 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
Xeridiem (Formerly Mri) 4700 S. Overland Dr., Tucson AZ
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