510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801783Substantially Equivalent

Catheter Irrigation Trays, #3300, 3310 &

The Healthcare Group Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801783 is the FDA 510(k) clearance record for CATHETER IRRIGATION TRAYS, #3300, 3310 &, a class II device, cleared for The Healthcare Group Laboratories, Inc. on under FDA product code EYN (Tray, Irrigation, Sterile). FDA records list 29 510(k) clearances for The Healthcare Group Laboratories, Inc., from to . As of , FDA records show no recalls naming K801783.

Clearance record

Decision date
Received
(16 days to decision)
Product code
EYN Tray, Irrigation, Sterile
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
The Healthcare Group Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
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