The following data is part of a premarket notification filed by Apollo Endosurgery, Inc. with the FDA for Sumo Access And Tissue Resection System.
| Device ID | K103155 |
| 510k Number | K103155 |
| Device Name: | SUMO ACCESS AND TISSUE RESECTION SYSTEM |
| Classification | Endoscope Channel Accessory |
| Applicant | APOLLO ENDOSURGERY, INC. 7000 BEE CAVES RD. SUITE 350 Austin, TX 78746 |
| Contact | Greg Mathison |
| Correspondent | Greg Mathison APOLLO ENDOSURGERY, INC. 7000 BEE CAVES RD. SUITE 350 Austin, TX 78746 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-26 |
| Decision Date | 2011-10-28 |
| Summary: | summary |