Panels › Gastroenterology, Urology › Product code FFS · Class 2
Image, Illumination, Fiberoptic, For Endoscope
Regulation 876.1500
0510(k)s in 12 months (26 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FFS
| Company | 510(k)s | Recalls |
|---|---|---|
| Cogent Light Technologies, Inc. | 2 | 0 |
| Incredivision, Inc. | 2 | 0 |
| KARL STORZ Endoscopy-America, Inc. | 2 | 0 |
| Smith & Nephew, Inc. | 2 | 0 |
| Accutech Medical Technologies, Inc. | 1 | 0 |
| Alm Surgical Equipment, Inc. | 1 | 0 |
| Cook Inc. | 0 | 1 |
| Cook Urological, Inc. | 1 | 0 |
| Douglas Manufacturer Co. | 1 | 0 |
| Dutch Ophthalmic USA, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2017 | Cook Inc. Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages Terminated |
FFS | K072521 |
| Jun 7, 2007 | Smith & Nephew, Inc Endoscopy Division Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810. Terminated |
FFS | K994084 |
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