The following data is part of a premarket notification filed by B.j.z.h.f. Panther Medical Equipment Co. Ltd. with the FDA for Panther Endo Linear Cutter Staplers With Single Use Loading Units.
| Device ID | K142577 |
| 510k Number | K142577 |
| Device Name: | PANTHER Endo Linear Cutter Staplers With Single Use Loading Units |
| Classification | Staple, Implantable |
| Applicant | B.J.Z.H.F. Panther Medical Equipment Co. Ltd. ROM 805, Ruichuang Mansion, NO. 9 Wangjing East Beijing, CN |
| Contact | Liu Yu |
| Correspondent | Chu Xiaoan CHU XIAOAN Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan ZhongRd Beijing, CN |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-12 |
| Decision Date | 2015-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06939282409918 | K142577 | 000 |
| 06939282409697 | K142577 | 000 |
| 06939282409680 | K142577 | 000 |
| 06939282409673 | K142577 | 000 |
| 06939282409666 | K142577 | 000 |
| 06939282409659 | K142577 | 000 |
| 06939282409642 | K142577 | 000 |
| 06939282409635 | K142577 | 000 |
| 06939282409628 | K142577 | 000 |
| 06939282409611 | K142577 | 000 |
| 06939282409604 | K142577 | 000 |
| 06939282408911 | K142577 | 000 |
| 06939282408904 | K142577 | 000 |
| 06939282408898 | K142577 | 000 |
| 06939282408881 | K142577 | 000 |
| 06939282408874 | K142577 | 000 |
| 06939282409703 | K142577 | 000 |
| 06939282409710 | K142577 | 000 |
| 06939282409901 | K142577 | 000 |
| 06939282409895 | K142577 | 000 |
| 06939282409888 | K142577 | 000 |
| 06939282409871 | K142577 | 000 |
| 06939282409864 | K142577 | 000 |
| 06939282409857 | K142577 | 000 |
| 06939282409840 | K142577 | 000 |
| 06939282409833 | K142577 | 000 |
| 06939282409826 | K142577 | 000 |
| 06939282409819 | K142577 | 000 |
| 06939282409802 | K142577 | 000 |
| 06939282409758 | K142577 | 000 |
| 06939282409741 | K142577 | 000 |
| 06939282409734 | K142577 | 000 |
| 06939282409727 | K142577 | 000 |
| 06939282408867 | K142577 | 000 |