The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Gordon Large-bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters And Sets.
| Device ID | K173035 |
| 510k Number | K173035 |
| Device Name: | Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters And Sets |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Contact | Erum B. Nasir |
| Correspondent | Erum B. Nasir Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Product Code | FGE |
| Subsequent Product Code | GBO |
| Subsequent Product Code | LJE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2018-05-01 |
| Summary: | summary |