510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K912972Substantially Equivalent

Flexiflo Over the Guidewire Jejunal Feeding Tube

Abbott Medical, Columbus OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912972 is the FDA 510(k) clearance record for FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE, a class II device, cleared for Abbott Laboratories on under FDA product code FPD (Tube, Feeding). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K912972.

Clearance record

Decision date
Received
(77 days to decision)
Product code
FPD Tube, Feeding
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Abbott Laboratories 625 Cleveland Ave., Columbus OH
510(k) summary
Statement
Third party review
No

Clearances, product code FPD

Trailing 12 months

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

FDA records show no clearances under product code FPD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260