510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923940Unknown

Irrigation Tray W/ Piston Syringe & Sterile Saline

American Healthcare Corp., South Plainfield NJ / Traditional, Unknown
FDA source (opens on fda.gov)

K923940 is the FDA 510(k) clearance record for IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE, a class II device, cleared for American Healthcare Corp. on under FDA product code EYN (Tray, Irrigation, Sterile). FDA records list 17 510(k) clearances for American Healthcare Corp., from to . As of , FDA records show no recalls naming K923940.

Clearance record

Decision date
Received
(316 days to decision)
Product code
EYN Tray, Irrigation, Sterile
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
American Healthcare Corp. One American Healthcare Plz., South Plainfield NJ
510(k) summary
Statement
Third party review
No

Clearances, product code EYN

Trailing 12 months

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

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