The following data is part of a premarket notification filed by Reach Surgical, Inc with the FDA for Reach Surgical Staplers.
| Device ID | K120179 |
| 510k Number | K120179 |
| Device Name: | REACH SURGICAL STAPLERS |
| Classification | Staple, Implantable |
| Applicant | REACH SURGICAL, INC P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong REACH SURGICAL, INC P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-20 |
| Decision Date | 2012-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B092CS340 | K120179 | 000 |
| B092CS310 | K120179 | 000 |
| B092CS280 | K120179 | 000 |
| B092CS250 | K120179 | 000 |