510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053410Substantially Equivalent

Gientriport with Universal Single Lumen Adaptor

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

K053410 is the FDA 510(k) clearance record for GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR, a class II device, cleared for Kendall on under FDA product code FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation). FDA records list 22 510(k) clearances for Kendall, from to . As of , FDA records show no recalls naming K053410.

Clearance record

Decision date
Received
(30 days to decision)
Product code
FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Kendall 15 Hampshire St., Mansfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FEG

Trailing 12 months

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

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