510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K113585Substantially Equivalent

Nasal/epistaxis Pack

Cogent Therapeutics, LLC, Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113585 is the FDA 510(k) clearance record for NASAL/EPISTAXIS PACK, a class I device, cleared for Cogent Therapeutics, LLC on under FDA product code LYA (Splint, Intranasal Septal). FDA records list one 510(k) clearance for Cogent Therapeutics, LLC. As of , FDA records show no recalls naming K113585.

Clearance record

Decision date
Received
(142 days to decision)
Product code
LYA Splint, Intranasal Septal
Regulation
21 CFR 874.4780
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Cogent Therapeutics, LLC 3637 Bernal Ave., Pleasanton CA
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