510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K801781Substantially Equivalent

Catheter Irrigation Syringes, #3100,3110

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

K801781 is the FDA 510(k) clearance record for CATHETER IRRIGATION SYRINGES, #3100,3110, a class II device, cleared for The Healthcare Group Laboratories, Inc. on under FDA product code KQT (Evacuator, Gastro-Urology). FDA records list 29 510(k) clearances for The Healthcare Group Laboratories, Inc., from to . As of , FDA records show no recalls naming K801781.

Clearance record

Decision date
Received
(16 days to decision)
Product code
KQT Evacuator, Gastro-Urology
Regulation
21 CFR 876.4370
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 KQT

Trailing 12 months

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

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