The following data is part of a premarket notification filed by Reach Surgical, Inc with the FDA for Reach Rcs Circular Stapler, Model Rcs21c, Rcs25c, Rcs28c, Rcs31c, Rcs34c.
| Device ID | K071023 |
| 510k Number | K071023 |
| Device Name: | REACH RCS CIRCULAR STAPLER, MODEL RCS21C, RCS25C, RCS28C, RCS31C, RCS34C |
| Classification | Staple, Implantable |
| Applicant | REACH SURGICAL, INC 4480 LAKE FOREST DR. SUITE 414 Cincinnati, OH 45242 |
| Contact | Rich Grant |
| Correspondent | Rich Grant REACH SURGICAL, INC 4480 LAKE FOREST DR. SUITE 414 Cincinnati, OH 45242 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-11 |
| Decision Date | 2008-08-28 |
| Summary: | summary |