K223890 is an FDA 510(k) clearance for the NAJA Gastrointestinal Catheter. This device is classified as a Catheter, Retention, Barium Enema With Bag (Class II - Special Controls, product code FGD).
Submitted by Chess Medical, Inc. (Montreal, CA). The FDA issued a Cleared decision on June 16, 2023, 171 days after receiving the submission on December 27, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K223890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2022 |
| Decision Date | June 16, 2023 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGD - Catheter, Retention, Barium Enema With Bag |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |