510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131177Substantially Equivalent

Sinuflush Lavage System

Hedgepath, LLC, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131177 is the FDA 510(k) clearance record for SINUFLUSH LAVAGE SYSTEM, a class I device, cleared for Hedgepath, LLC on under FDA product code KAR (Irrigator, Sinus). FDA records list one 510(k) clearance for Hedgepath, LLC. As of , FDA records show no recalls naming K131177.

Clearance record

Decision date
Received
(148 days to decision)
Product code
KAR Irrigator, Sinus
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Hedgepath, LLC 324 S. Hyde Park Ave. Suite 350, Tampa FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KAR

Trailing 12 months

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

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