510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K810185Substantially Equivalent

Irrigation Syringe

Karoco Intl., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810185 is the FDA 510(k) clearance record for IRRIGATION SYRINGE, a class II device, cleared for Karoco Intl. on under FDA product code FQH (Lavage, Jet). FDA records list one 510(k) clearance for Karoco Intl. As of , FDA records show no recalls naming K810185.

Clearance record

Decision date
Received
(381 days to decision)
Product code
FQH Lavage, Jet
Regulation
21 CFR 880.5475
Device class
Class II
Review panel
General Hospital
Applicant
Karoco Intl. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FQH

Trailing 12 months
2 clearances under product code FQH in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FQH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260