K173355 is an FDA 510(k) clearance for the Gastric Sizing Balloon Catheter. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on November 17, 2017, 23 days after receiving the submission on October 25, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K173355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | October 25, 2017 |
| Decision Date | November 17, 2017 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |