The following data is part of a premarket notification filed by Reach Surgical, Inc. with the FDA for Reach And Cq'ence Circular Staplers.
| Device ID | K192566 |
| 510k Number | K192566 |
| Device Name: | Reach And CQ'ENCE Circular Staplers |
| Classification | Staple, Implantable |
| Applicant | Reach Surgical, Inc. 120 Xinxing Road West Zone, TEDA Tianjin, CN 300462 |
| Contact | Mark Goldin |
| Correspondent | Rich Grant SeCQure Surgical 4480 Lake Forest Dr. Cincinnati, OH 45242 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-18 |
| Decision Date | 2019-10-17 |