510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031617Substantially Equivalent

Mediplus Single Use Lower Gi Manometry Catheter

Mediplus Ltd., Potomac MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031617 is the FDA 510(k) clearance record for MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER, a class II device, cleared for Mediplus , Ltd. on under FDA product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube). FDA records list 4 510(k) clearances for Mediplus , Ltd., from to . As of , FDA records show no recalls naming K031617.

Clearance record

Decision date
Received
(238 days to decision)
Product code
KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mediplus , Ltd. 9109 Copenhaver Dr., Potomac MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KLA

Trailing 12 months

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

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