Product code GDB— Gastroenterology, Urology

FDA has cleared 7 devices under product code GDB between 1981 and 2003, filed by 7 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.

• 20031 clearance
• 19961 clearance
• 19941 clearance
• 19881 clearance
• 19861 clearance
• 19841 clearance
• 19811 clearance

• Regtec1 clearance
• Pentax Precision Instrument Corp.1 clearance
• Olympus Corp.1 clearance
• Medical Diagnostics, Ca.1 clearance
• Matrix Medica, Inc.1 clearance
• Designs For Vision, Inc.1 clearance
• Cuda Products Co.1 clearance

• K032283 — DESIGNS FOR VISION FIBEROPTIC LIGHTDesigns For Vision, Inc.·2003-08-20
• K961536 — FLEXSCOPEMatrix Medica, Inc.·1996-09-18
• K935818 — ENDOSCOPECuda Products Co.·1994-07-13
• K882061 — OLYMPUS GF-UM3/EU-M3Olympus Corp.·1988-11-15
• K855151 — FRITCH OPHTHALMIC ENDOSCOPERegtec·1986-02-19
• K843900 — FOCUSCOPE UNIVERSAL SYSTEMMedical Diagnostics, Ca.·1984-12-06
• K810007 — PENTAX UPPER G.I. FIBERSCOPE, #FG-34Pentax Precision Instrument Corp.·1981-01-15