Product code KQT— Gastroenterology, Urology

FDA has cleared 14 devices under product code KQT between 1979 and 1996, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19961 clearance
• 19922 clearances
• 19911 clearance
• 19882 clearances
• 19861 clearance
• 19831 clearance
• 19812 clearances
• 19803 clearances
• 19791 clearance

• The Healthcare Group Laboratories, Inc.2 clearances
• Northgate Technologies, Inc.2 clearances
• Van-Tec, Inc.1 clearance
• The Urology Group1 clearance
• Sage Products, Inc.1 clearance
• R. J. Ltd., Ind.1 clearance
• Mitron Technologies, Inc.1 clearance
• J. H. Emerson Co.1 clearance
• Electro Medical Systems SA1 clearance
• Davol, Inc.1 clearance

• K964111 — LITHOVAC SUCTION/ASPIRATION PROBEElectro Medical Systems SA·1996-12-16
• K921088 — EVACUATOR, GASTRO-UROLOGYNorthgate Technologies, Inc.·1992-10-28
• K921451 — EVACUATOR, GASTRO-UROLOGYNorthgate Technologies, Inc.·1992-10-28
• K910728 — CLEANFLOW SYSTEMMitron Technologies, Inc.·1991-04-01
• K880099 — VAN-TEC BLADDER EVACUATORVan-Tec, Inc.·1988-03-02
• K874493 — BELLA - VAC IRRIGATORBel-Can Industries·1988-02-05
• K860266 — ELLIK EVACUATORR. J. Ltd., Ind.·1986-03-05
• K830546 — DOSIMETRIC RELEASEAmerican Hospital Supply Corp.·1983-05-25
• K811779 — ROSS-EMERSON PUMP, MODEL 55-RJ. H. Emerson Co.·1981-07-13
• K810739 — SUCTION WOUND DRAINAGE DEVICEThe Urology Group·1981-06-26
• K801781 — CATHETER IRRIGATION SYRINGES, #3100,3110The Healthcare Group Laboratories, Inc.·1980-08-13
• K801782 — GENERAL PURPOSE IRRIGATING/ASPIR SYR.The Healthcare Group Laboratories, Inc.·1980-08-13
• K800397 — ELLIK BLADDER EVACUATORSage Products, Inc.·1980-03-10
• K791306 — ELLIK EVACUATORDavol, Inc.·1979-08-03