K220730 is an FDA 510(k) clearance for the allFlex Ureteral Catheters, Krait Ureteral Catheters. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on October 13, 2022, 213 days after receiving the submission on March 14, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K220730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2022 |
| Decision Date | October 13, 2022 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KOD - Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |