The following data is part of a premarket notification filed by Ezisurg Medical Co., Ltd. with the FDA for Easyendo Lite Linear Cutting Stapler And Loading Unit For Single Use.
| Device ID | K210909 |
| 510k Number | K210909 |
| Device Name: | EasyEndo Lite Linear Cutting Stapler And Loading Unit For Single Use |
| Classification | Staple, Implantable |
| Applicant | Ezisurg Medical Co., Ltd. Rm. 103, Bldg. 2, No.1690 Cailun Rd., China (Shanghai) Pilot Shanghai, CN 201203 |
| Contact | Jingtian Ren |
| Correspondent | Diana Hong Mid-Linking Consulting Co., Ltd. P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2021-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16925776102578 | K210909 | 000 |
| 66925776102481 | K210909 | 000 |
| 66925776102498 | K210909 | 000 |
| 66925776102504 | K210909 | 000 |
| 66925776102511 | K210909 | 000 |
| 66925776102528 | K210909 | 000 |
| 16925776102585 | K210909 | 000 |
| 16925776102592 | K210909 | 000 |
| 16925776102608 | K210909 | 000 |
| 16925776102615 | K210909 | 000 |
| 06925776102441 | K210909 | 000 |
| 66925776102450 | K210909 | 000 |
| 66925776102467 | K210909 | 000 |
| 66925776102535 | K210909 | 000 |
| 06925776102540 | K210909 | 000 |
| 66925776102474 | K210909 | 000 |