510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983665Substantially Equivalent

Manometric Assemblies

Dentsleeve Pty., Ltd., Parkside South Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983665 is the FDA 510(k) clearance record for MANOMETRIC ASSEMBLIES, a class II device, cleared for Dentsleeve Pty., Ltd. on under FDA product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube). FDA records list 3 510(k) clearances for Dentsleeve Pty., Ltd., from to . As of , FDA records show no recalls naming K983665.

Clearance record

Decision date
Received
(210 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
Dentsleeve Pty., Ltd. 56 A/B Glen Osmond Rd., Parkside South Australia, AU
510(k) summary
Summary
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