K170323 is an FDA 510(k) clearance for the Entuit Start Initial Placement Gastrostomy Set. This device is classified as a Tube, Gastro-enterostomy (Class II - Special Controls, product code KGC).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on September 14, 2017, 225 days after receiving the submission on February 1, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K170323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2017 |
| Decision Date | September 14, 2017 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KGC — Tube, Gastro-enterostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |