The following data is part of a premarket notification filed by Beijing Biosis Healing Biological Technology Co., Ltd. with the FDA for Disposable Laparoscope Trocar.
| Device ID | K201641 |
| 510k Number | K201641 |
| Device Name: | Disposable Laparoscope Trocar |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Beijing Biosis Healing Biological Technology Co., Ltd. No.6 Plant West, Valley No.1 Bio-medicine Industry Park Daxing District Beijing, CN 102600 |
| Contact | Jiali Zhou |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-16 |
| Decision Date | 2020-08-06 |