Product Code: KYG FDA class 1 21 CFR 886.4360

Device, Irrigation, Ocular Surgery

Ophthalmic

The Ocular Surgery Irrigation Device is an ophthalmic device used to continuously bathe and irrigate the eye during surgical procedures, maintaining intraocular pressure and removing debris, blood, or surgical byproducts from the surgical field. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KYG, regulated under 21 CFR 886.4360, in the Ophthalmic medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: KYG
Device Class: FDA class 1
Regulation Number: 886.4360
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 40 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K010353	MED-LOGICS DISPOSABLE ALK TUBING	Apr 27, 2001	Substantially Equivalent	Med-Logics, Inc.
K003036	TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025	Dec 22, 2000	Substantially Equivalent	Retinalabs.Com
K993591	BLADEWORKS DISPOSABLE ALK TUBING	Dec 28, 1999	Substantially Equivalent	Blade Works, Inc.
K981116	SOVEREIGN CATARACT EXTRACTION SYSTEM	May 19, 1998	Substantially Equivalent	Allergan, Inc.
K980647	EYE IRRIGATOR MODEL #2020	May 15, 1998	Substantially Equivalent	Eye-Deal Ocular Safety Products, Inc.
K974561	MOISTAIR FLUID AIR TUBING SET	Feb 19, 1998	Substantially Equivalent	American Medical Devices, Inc.
K971173	ML DISPOSABLE ALK TUBING	May 22, 1997	Substantially Equivalent	Med-Logics, Inc.
K970161	HEDGES CORNEAL WETTING PAK	Mar 25, 1997	Substantially Equivalent	Hedges Cwp, Inc.
K954842	D.O.R.C. VFI/VFE SYSTEM	Apr 15, 1996	Substantially Equivalent	Dutch Ophthalmic USA, Inc.
K945171	DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE	Feb 08, 1995	Substantially Equivalent	Boston Surgical Products, Inc.
K940392	PEREGRINE PIC MINIPULATOR	Aug 23, 1994	Substantially Equivalent	Peregrine Surgical , Ltd.
K935226	I/V POLE	Feb 16, 1994	Substantially Equivalent	Optical Micro Systems, Inc.
K935003	ELECTRIC I/V POLE OR EIVP2	Jan 25, 1994	Substantially Equivalent	Optical Micro Systems, Inc.
K925921	MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE	Dec 06, 1993	Substantially Equivalent	Site Microsurgical Systems, Inc.
K924999	AUTOPOLE REGULATOR SYSTEM	Dec 24, 1992	Substantially Equivalent	Escalon Trek Medical
K924052	INFINITY MICRO IRRIGATOR	Dec 23, 1992	Substantially Equivalent	Infinity Surgical Technology, Inc.
K922996	MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS	Jul 27, 1992	Substantially Equivalent	Chiron Vision Corp.
K922180	LEWICKY O.R.S. TUBING	Jul 02, 1992	Substantially Equivalent	O.R. Specialties, Inc.
K915808	AQUEOUS PARACENTESIS PIPET	Mar 19, 1992	Substantially Equivalent	Visitec Co.
K914587	GRIESHABER AIR/FLUID TUBING SET	Jan 23, 1992	Substantially Equivalent	Grieshaber & Co.
K904186	SITE DIAPHRAGM CASSETTE	Nov 21, 1990	Substantially Equivalent	Site Microsurgical Systems, Inc.
K881518	INFUSION HANDLE	Aug 22, 1988	Substantially Equivalent	B&B Medical Assoc., Inc.
K881517	B & B I/A HANDPIECE	Aug 22, 1988	Substantially Equivalent	B&B Medical Assoc., Inc.
K881682	ALCON SITE(R)-COMPATIBLE CASSETTE	Jul 01, 1988	Substantially Equivalent	Alcon Laboratories
K880543	UNI-PORT	Jul 01, 1988	Substantially Equivalent	Surgeon Surgical Instrumentation, Inc.
K871454	MORGAN THERAPEUTIC LENS	Jun 19, 1987	Substantially Equivalent	Mortan, Inc.
K861203	MULTI-SPIKE	Apr 28, 1986	Substantially Equivalent	Surgeon Surgical Instrumentation, Inc.
K860544	BACSTOP FILTER IRRIGATION SUPPLY KIT	Apr 04, 1986	Substantially Equivalent	Staar Surgical Co.
K861013	ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)	Mar 31, 1986	Substantially Equivalent	Ameritek, Inc.
K853243	VISITEC IRRIGATION CONTROL SYSTEM	Sep 11, 1985	Substantially Equivalent	Visitec Co.
K845039	OPERAID DISPOS. IRRIGATING KNIFE	Mar 05, 1985	Substantially Equivalent	Jedmed Instrument Co.
K841807	OPERAID NUCLEUS	Nov 21, 1984	Substantially Equivalent	Jedmed Instrument Co.
K832787	ELECATH HEPARIN COATED THERMAL DILUTION	Oct 04, 1983	Substantially Equivalent	Electro-Catheter Corp.
K831996	MICRO SURGICAL HANDLE	Jul 12, 1983	Substantially Equivalent	Visitec Co.
K821897	LENS	Jan 05, 1983	Substantially Equivalent	Mortan, Inc.
K820889	ASPIRATOR/IRRIGATOR OR I/A UNIT	May 05, 1982	Substantially Equivalent	Mid Laboratories, Inc.
K820680	DISPOSABLE TUBING SETS	Apr 09, 1982	Substantially Equivalent	Innovative Surgical Products, Inc.
K802332	INTRAJECT	Dec 22, 1980	Substantially Equivalent	General Medical Engineering Corp.
K801822	NU-VISION DISP. OPHTHALMIC DRESSING TRAY	Sep 30, 1980	Substantially Equivalent	Summit Optics, Inc.
K760820	NALGENE EMERGENCY EYE WASH	Oct 20, 1976	Substantially Equivalent	Nagle Co.