510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100163Substantially Equivalent

Nutrisafe 2 Feeding Tubes Model 362.Xxx. 1362.Xxx

Vygon Corp., Montgomeryville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100163 is the FDA 510(k) clearance record for NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX, a class II device, cleared for Vygon Corp. on under FDA product code FPD (Tube, Feeding). FDA records list 2 510(k) clearances for Vygon Corp., from to . As of , FDA records show no recalls naming K100163.

Clearance record

Decision date
Received
(631 days to decision)
Product code
FPD Tube, Feeding
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Vygon Corp. 103a Park Rd., Montgomeryville PA
510(k) summary
Summary PDF
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPD, 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