Endoscope, Fiber Optic
FDA product code GDB · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032283 | Designs for Vision Fiberoptic LightGDB · Special | Designs For Vision, Inc. | 08/20/2003SE |
| K961536 | FlexscopeGDB · Traditional | Matrix Medica, Inc. | 09/18/1996SE |
| K935818 | EndoscopeGDB · Traditional | Cuda Products Co. | 07/13/1994SE |
| K882061 | Olympus GF-UM3/EU-M3GDB · Traditional | Olympus Corp. | 11/15/1988SE |
| K855151 | Fritch Ophthalmic EndoscopeGDB · Traditional | Regtec | 02/19/1986SE |
| K843900 | Focuscope Universal SystemGDB · Traditional | Medical Diagnostics, Ca. | 12/06/1984SE |
| K810007 | Pentax Upper G.I. Fiberscope, #FG-34GDB · Traditional | Pentax Precision Instrument Corp. | 01/15/1981SE |