FDA 510(k) Applications for Medical Device Product Code "ODF"
(Mini Endoscope, Gastroenterology-Urology)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K052194 | BOSTON SCIENTIFIC CORP. | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR | 08/24/2005 |
| K050403 | BOSTON SCIENTIFIC CORP. | SPYGLASS DIRECT VISULATION PROBE | 03/04/2005 |
| K090170 | BOSTON SCIENTIFIC CORP. | SPYSCOPE ACCESS AND DELIVERY CATHETER | 02/04/2009 |
| K092739 | C-LINK MICRO IMAGING, INC | MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE | 01/12/2010 |
| K963354 | FIVE STAR MEDICAL, INC. | 5 STAR MEDICAL ENDOSCOPE | 09/08/1997 |
| K091962 | LUMENIS, INC. | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 | 09/30/2009 |
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