Anaheim, CA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EZN | Dilator, Catheter, Ureteral | Class II | Gastroenterology, Urology | 1 | 2023-05-05 |
| KOD | Catheter, Urological | Class II | Gastroenterology, Urology | 1 | 2022-10-13 |
| MQK | Labware, Assisted Reproduction | Class II | Obstetrics/Gynecology | 1 | 2021-06-04 |
| MQF | Catheter, Assisted Reproduction | Class II | Obstetrics/Gynecology | 1 | 2020-07-01 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-05-05 | K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | EZN | Class II | Gastroenterology, Urology |
| 2022-10-13 | K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | KOD | Class II | Gastroenterology, Urology |
| 2021-06-04 | K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | MQK | Class II | Obstetrics/Gynecology |
| 2020-07-01 | K200248 | Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators | MQF | Class II | Obstetrics/Gynecology |