Panels › Gastroenterology, Urology › Product code ODF · Class 2
Mini Endoscope, Gastroenterology-Urology
Regulation 876.1500
0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ODF
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 3 | 0 |
| Candela Laser Corp. | 3 | 0 |
| C-Link Micro Imaging, Inc. | 1 | 0 |
| Five Star Medical, Inc. | 1 | 0 |
| Lumenis, Inc. | 1 | 0 |
| Medical Laser, Inc. | 1 | 0 |
| Origin Medsystems, Inc. | 1 | 0 |
| Ovamed Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 12, 2010 | K092739 | MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE C-Link Micro Imaging, Inc. | ODF |
| Sep 30, 2009 | K091962 | POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 Lumenis, Inc. | ODF |
| Feb 4, 2009 | K090170 | SPYSCOPE ACCESS AND DELIVERY CATHETER Boston Scientific Corp | ODF |
| Aug 24, 2005 | K052194 | SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR Boston Scientific Corp | ODF |
| Mar 4, 2005 | K050403 | SPYGLASS DIRECT VISULATION PROBE Boston Scientific Corp | ODF |
| Sep 8, 1997 | K963354 | 5 STAR MEDICAL ENDOSCOPE Five Star Medical, Inc. | ODF |
| Mar 22, 1995 | K943593 | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM Ovamed Corp. | ODF |
| Jun 17, 1994 | K941230 | MINI-UB ENDOSCOPES Candela Laser Corp. | ODF |
| Oct 19, 1993 | K933106 | ENDOSCOPE Origin Medsystems, Inc. | ODF |
| Aug 12, 1991 | K912089 | MODIFIED SERIES 2100 ENDOSCOPES Medical Laser, Inc. | ODF |
| Apr 12, 1991 | K910732 | CANDELA MINI-UB ENDOSCOPE Candela Laser Corp. | ODF |
| Feb 19, 1988 | K874858 | LASERTRIPTER MINISCOPE Candela Laser Corp. | ODF |
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