The following data is part of a premarket notification filed by Changzhou Detain Medical Devices Co., Ltd. with the FDA for Sterile Endoscope Biopsy Sampling Needle.
| Device ID | K171956 |
| 510k Number | K171956 |
| Device Name: | Sterile Endoscope Biopsy Sampling Needle |
| Classification | Biopsy Needle |
| Applicant | Changzhou Detain Medical Devices Co., Ltd. No.47, North Qingyang Rd, Tianning District Changzhou, CN 213017 |
| Contact | Zhengrong Ding |
| Correspondent | Ethan Liu Shanghai Thinkwell Consulting Co., Ltd. Xinling Rd, 211/6F Shanghai, CN 201100 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-29 |
| Decision Date | 2017-12-12 |
| Summary: | summary |