Product code KYG— Ophthalmic

FDA has cleared 40 devices under product code KYG between 1976 and 2001, filed by 31 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20011 clearance
• 20001 clearance
• 19991 clearance
• 19983 clearances
• 19972 clearances
• 19961 clearance
• 19951 clearance
• 19943 clearances
• 19931 clearance
• 19926 clearances
• 19901 clearance
• 19884 clearances
• 19871 clearance
• 19863 clearances
• 19852 clearances

• Visitec Co.3 clearances
• Surgeon Surgical Instrumentation, Inc.2 clearances
• Site Microsurgical Systems, Inc.2 clearances
• Optical Micro Systems, Inc.2 clearances
• Mortan, Inc.2 clearances
• Med-Logics, Inc.2 clearances
• Jedmed Instrument Co.2 clearances
• B&B Medical Assoc., Inc.2 clearances
• Summit Optics, Inc.1 clearance
• Staar Surgical Co.1 clearance

• K010353 — MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.·2001-04-27
• K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.Com·2000-12-22
• K993591 — BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.·1999-12-28
• K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.·1998-05-19
• K980647 — EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.·1998-05-15
• K974561 — MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, Inc.·1998-02-19
• K971173 — ML DISPOSABLE ALK TUBINGMed-Logics, Inc.·1997-05-22
• K970161 — HEDGES CORNEAL WETTING PAKHedges Cwp, Inc.·1997-03-25
• K954842 — D.O.R.C. VFI/VFE SYSTEMDutch Ophthalmic USA, Inc.·1996-04-15
• K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECEBoston Surgical Products, Inc.·1995-02-08
• K940392 — PEREGRINE PIC MINIPULATORPeregrine Surgical , Ltd.·1994-08-23
• K935226 — I/V POLEOptical Micro Systems, Inc.·1994-02-16
• K935003 — ELECTRIC I/V POLE OR EIVP2Optical Micro Systems, Inc.·1994-01-25
• K925921 — MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTESite Microsurgical Systems, Inc.·1993-12-06
• K924999 — AUTOPOLE REGULATOR SYSTEMEscalon Trek Medical·1992-12-24
• K924052 — INFINITY MICRO IRRIGATORInfinity Surgical Technology, Inc.·1992-12-23
• K922996 — MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICSChiron Vision Corp.·1992-07-27
• K922180 — LEWICKY O.R.S. TUBINGO.R. Specialties, Inc.·1992-07-02
• K915808 — AQUEOUS PARACENTESIS PIPETVisitec Co.·1992-03-19
• K914587 — GRIESHABER AIR/FLUID TUBING SETGrieshaber & Co.·1992-01-23
• K904186 — SITE DIAPHRAGM CASSETTESite Microsurgical Systems, Inc.·1990-11-21
• K881517 — B & B I/A HANDPIECEB&B Medical Assoc., Inc.·1988-08-22
• K881518 — INFUSION HANDLEB&B Medical Assoc., Inc.·1988-08-22
• K880543 — UNI-PORTSurgeon Surgical Instrumentation, Inc.·1988-07-01
• K881682 — ALCON SITE(R)-COMPATIBLE CASSETTEAlcon Laboratories·1988-07-01
• K871454 — MORGAN THERAPEUTIC LENSMortan, Inc.·1987-06-19
• K861203 — MULTI-SPIKESurgeon Surgical Instrumentation, Inc.·1986-04-28
• K860544 — BACSTOP FILTER IRRIGATION SUPPLY KITStaar Surgical Co.·1986-04-04
• K861013 — ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)Ameritek, Inc.·1986-03-31
• K853243 — VISITEC IRRIGATION CONTROL SYSTEMVisitec Co.·1985-09-11
• K845039 — OPERAID DISPOS. IRRIGATING KNIFEJedmed Instrument Co.·1985-03-05
• K841807 — OPERAID NUCLEUSJedmed Instrument Co.·1984-11-21
• K832787 — ELECATH HEPARIN COATED THERMAL DILUTIONElectro-Catheter Corp.·1983-10-04
• K831996 — MICRO SURGICAL HANDLEVisitec Co.·1983-07-12
• K821897 — LENSMortan, Inc.·1983-01-05
• K820889 — ASPIRATOR/IRRIGATOR OR I/A UNITMid Laboratories, Inc.·1982-05-05
• K820680 — DISPOSABLE TUBING SETSInnovative Surgical Products, Inc.·1982-04-09
• K802332 — INTRAJECTGeneral Medical Engineering Corp.·1980-12-22
• K801822 — NU-VISION DISP. OPHTHALMIC DRESSING TRAYSummit Optics, Inc.·1980-09-30
• K760820 — NALGENE EMERGENCY EYE WASHNagle Co.·1976-10-20