The following data is part of a premarket notification filed by Ezisurg Medical Co., Ltd. with the FDA for Easylctm Linear Cutter Staplers And Loading Units Fot Single Use; Easycstm Circular Stapler For Single Use.
| Device ID | K181657 |
| 510k Number | K181657 |
| Device Name: | EasyLCTM Linear Cutter Staplers And Loading Units Fot Single Use; EasyCSTM Circular Stapler For Single Use |
| Classification | Staple, Implantable |
| Applicant | Ezisurg Medical Co., Ltd. Rm. 103, Bldg.2, No.1690 Cailun Road China (Shanghai) Pilot Free Trade Zone Shanghai, CN 201203 |
| Contact | Liang Xia |
| Correspondent | Diana Hong Mid-Link 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 | 2018-06-22 |
| Decision Date | 2019-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 66925776123608 | K181657 | 000 |
| 16925776119293 | K181657 | 000 |
| 16925776119286 | K181657 | 000 |
| 16925776119279 | K181657 | 000 |
| 16925776112645 | K181657 | 000 |
| 16925776112638 | K181657 | 000 |
| 16925776112621 | K181657 | 000 |
| 16925776112614 | K181657 | 000 |
| 16925776112607 | K181657 | 000 |
| 16925776112591 | K181657 | 000 |
| 16925776112584 | K181657 | 000 |
| 66925776119304 | K181657 | 000 |
| 66925776119328 | K181657 | 000 |
| 66925776119335 | K181657 | 000 |
| 16925776119439 | K181657 | 000 |
| 16925776119422 | K181657 | 000 |
| 16925776119415 | K181657 | 000 |
| 16925776119408 | K181657 | 000 |
| 16925776119392 | K181657 | 000 |
| 16925776119385 | K181657 | 000 |
| 16925776119378 | K181657 | 000 |
| 66925776119366 | K181657 | 000 |
| 66925776119359 | K181657 | 000 |
| 66925776119342 | K181657 | 000 |
| 16925776112577 | K181657 | 000 |