The following data is part of a premarket notification filed by Medigus Ltd. with the FDA for Muse System.
| Device ID | K151001 |
| 510k Number | K151001 |
| Device Name: | MUSE System |
| Classification | Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) |
| Applicant | MEDIGUS LTD. BUILDING 7A, OMER IMDUSTRIAL PARK Omer, IL 84965 |
| Contact | Yaniv Sagie |
| Correspondent | Sheila S. Stevens SHEILA S. STEVENS 2121 NORTH CALIFORNIA BLVD. SUITE 290 Walnut Creek, CA 94596 |
| Product Code | ODE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-06-05 |
| Summary: | summary |