The following data is part of a premarket notification filed by Medigus, Ltd. with the FDA for Srs Endoscopic Stapling System.
| Device ID | K132151 |
| 510k Number | K132151 |
| Device Name: | SRS ENDOSCOPIC STAPLING SYSTEM |
| Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Applicant | MEDIGUS, LTD. 555 13TH STREET, NW COLUMBIA SQUARE Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan MEDIGUS, LTD. 555 13TH STREET, NW COLUMBIA SQUARE Washington, DC 20004 |
| Product Code | ODE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-11 |
| Decision Date | 2014-03-19 |
| Summary: | summary |