510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K011544Substantially Equivalent

Hadgel, 4 Gram/syringe

Seikagaku Corp., Kitty Hawk NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011544 is the FDA 510(k) clearance record for HADGEL, 4 GRAM/SYRINGE, a class I device, cleared for Seikagaku Corp. on under FDA product code LYA (Splint, Intranasal Septal). FDA records list one 510(k) clearance for Seikagaku Corp. As of , FDA records show no recalls naming K011544.

Clearance record

Decision date
Received
(89 days to decision)
Product code
LYA Splint, Intranasal Septal
Regulation
21 CFR 874.4780
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Seikagaku Corp. 90 Poteskeet Trl., Kitty Hawk NC
510(k) summary
Summary
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