Product Code: EYN FDA class 2 21 CFR 876.5980

Tray, Irrigation, Sterile

Gastroenterology, Urology

The sterile irrigation tray is a pre-packaged sterile collection of supplies used to perform urological or surgical irrigation procedures, typically containing tubing, drainage bags, and ancillary components for bladder or wound irrigation. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is EYN, regulated under 21 CFR 876.5980 in the Gastroenterology, Urology specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EYN
Device Class: FDA class 2
Regulation Number: 876.5980
Medical Specialty: Gastroenterology, Urology
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K944882	IRRIGATION TRAY	Jan 12, 1995	Substantially Equivalent	Clinical Resources, Inc.
K923941	IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE	Jun 17, 1993	Unknown	American Healthcare Corp.
K923940	IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE	Jun 17, 1993	Unknown	American Healthcare Corp.
K923939	IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER	Jun 17, 1993	Unknown	American Healthcare Corp.
K923938	IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER	Jun 17, 1993	Unknown	American Healthcare Corp.
K900148	KIT PAK IRRIGATION TRAY	Apr 23, 1990	Unknown	Kit Pak, Inc.
K900737	PISTON IRRIGATION TRAY	Apr 19, 1990	Unknown	Orion Life Systems, Inc.
K900736	BULB IRRIGATION TRAY	Apr 17, 1990	Unknown	Orion Life Systems, Inc.
K801783	CATHETER IRRIGATION TRAYS, #3300, 3310 &	Aug 13, 1980	Substantially Equivalent	The Healthcare Group Laboratories, Inc.
K792082	GAVAGE FEEDING SET	Nov 13, 1979	Substantially Equivalent	Medical Devices, Inc.
K791020	FLUID ADMINISTRATION SET FA-3160	Jun 27, 1979	Substantially Equivalent	Burron Medical Products, Inc.
K790607	GREENLINE IRRIGATION TRAYS	May 11, 1979	Substantially Equivalent	Snyder Laboratories, Inc.
K781918	IRRIGATOR, BODY CAVITY	Feb 15, 1979	Substantially Equivalent	Bci, Inc.
K781748	IRRIGATION TRAY	Dec 12, 1978	Substantially Equivalent	Intermed, Inc.
K760047	TRAY, BLADDER IRRIGATION	Mar 01, 1977	Substantially Equivalent	M-C Ind., Inc.