510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062362Substantially Equivalent

Single Use Esophageal Manometey Catheters and Single Use Ano-Rectal Manometry Catheters

Sarmed SRL, Medolla, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062362 is the FDA 510(k) clearance record for SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS, a class II device, cleared for Sarmed Srl on under FDA product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube). FDA records list one 510(k) clearance for Sarmed Srl. As of , FDA records show no recalls naming K062362.

Clearance record

Decision date
Received
(242 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
Sarmed Srl Via Degli Artigiani, 6, Medolla, IT
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