510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K141704Substantially Equivalent

Novashield Injectable Nasal Packing and Stent

Medtronic, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141704 is the FDA 510(k) clearance record for NOVASHIELD INJECTABLE NASAL PACKING AND STENT, a class I device, cleared for Medtronic, Inc. on under FDA product code LYA (Splint, Intranasal Septal). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K141704.

Clearance record

Decision date
Received
(104 days to decision)
Product code
LYA Splint, Intranasal Septal
Regulation
21 CFR 874.4780
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Medtronic, Inc. 6743 Southpoint Dr. N., Jacksonville FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LYA

Trailing 12 months

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

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