The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Gastric Sizing Balloon Catheter.
| Device ID | K173355 |
| 510k Number | K173355 |
| Device Name: | Gastric Sizing Balloon Catheter |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Contact | Colin Jacobs |
| Correspondent | Colin Jacobs Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-25 |
| Decision Date | 2017-11-17 |
| Summary: | summary |