The following data is part of a premarket notification filed by Zhejiang Chuangxiang Medical Technology Co., Ltd. with the FDA for Disposable Biopsy Valve.
| Device ID | K173758 |
| 510k Number | K173758 |
| Device Name: | Disposable Biopsy Valve |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou, CN 311100 |
| Contact | Lucius Long |
| Correspondent | Lucius Long Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road Hanzhou, CN 311100 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-11 |
| Decision Date | 2018-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26970401813548 | K173758 | 000 |
| 06970401812585 | K173758 | 000 |
| 16970401817150 | K173758 | 000 |
| 16970401817174 | K173758 | 000 |
| 26970401814361 | K173758 | 000 |
| 26970401814071 | K173758 | 000 |
| 26970401814057 | K173758 | 000 |