Product code FEH— Gastroenterology, Urology

FDA has cleared 3 devices under product code FEH between 1981 and 2013, filed by 2 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.

• 20131 clearance
• 20121 clearance
• 19811 clearance

• Optim, LLC2 clearances
• American Cystocope Makers, Inc.1 clearance

• K130489 — ELECTRODE, FLEXIBLE SUCTION COAGULATOROptim, LLC·2013-04-19
• K122593 — PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2Optim, LLC·2012-09-13
• K803214 — ACMI BIPOLAR HEMOSTATIC ELECTRODEAmerican Cystocope Makers, Inc.·1981-01-15