Company ยท CN
Anrei Medical (Hangzhou) Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2022. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
| ODC | Endoscope Channel Accessory | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 2022 | K212999 | Multi-Functional Electrosurgical Knife Anrei Medical (Hangzhou) Co., Ltd., CN | KNS |
| May 28, 2021 | K210917 | Single Use Injection Needle Anrei Medical (Hangzhou) Co., Ltd., CN | FBK |
| Apr 29, 2021 | K202987 | Rescue Pulmonary Grasping Forceps Anrei Medical (Hangzhou) Co., Ltd., CN | EOQ |
| Apr 27, 2021 | K210660 | Stone Retrieval Balloon Catheter Anrei Medical (Hangzhou) Co., Ltd., CN | GCA |
| Oct 19, 2020 | K201771 | Single Use Rotatable and Repositionable Hemoclip Anrei Medical (Hangzhou) Co., Ltd., CN | PKL |
| May 14, 2020 | K192048 | Single Use Endoscope Valves Set Anrei Medical (Hangzhou) Co., Ltd., CN | ODC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||