Panels › Gastroenterology, Urology › Product code FCW · Class 2
Light Source, Fiberoptic, Routine
Regulation 876.1500
0510(k)s in 12 months (31 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in FCW
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corp. | 0 | 4 |
| KARL STORZ Endoscopy-America, Inc. | 2 | 0 |
| Luxtec Corp. | 2 | 0 |
| Pilling Co. | 2 | 0 |
| Stryker Corp. | 1 | 1 |
| Welch Allyn, Inc. | 2 | 0 |
| Acueity, Inc. | 1 | 0 |
| Angiolaz, Inc. | 1 | 0 |
| Circon Video | 1 | 0 |
| Corin USA | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2023 | Stryker Corporation SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200 Open, Classified |
FCW | K082813 |
| Dec 2, 2011 | Integra LifeSciences Corp. Integra Surgical Luxtec MLX Light Source
Catalog Numbers: 00MLXEU Terminated |
FCW | K081477 |
| Dec 2, 2011 | Integra LifeSciences Corp. Integra Surgical Luxtec MLX Light Source
Catalog Numbers: 00MLXAU
Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable fo Terminated |
FCW | K081477 |
| Dec 2, 2011 | Integra LifeSciences Corp. Integra Surgical Luxtec MLX Light Source
Catalog Numbers: 00MLX
Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for Terminated |
FCW | K081477 |
| Apr 25, 2011 | Integra LifeSciences Corp. Luxtec MLX 300 Watt Xenon Light Source,
Model OOMLX; Surgical/Medical Light Source
This light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical Terminated |
FCW | K081477 |
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