The following data is part of a premarket notification filed by Apollo Endosurgery, Inc. with the FDA for Endoscopic Monopolar Scissors, Models Ems-235, Ems-165.
| Device ID | K090583 |
| 510k Number | K090583 |
| Device Name: | ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 |
| Classification | Forceps, Biopsy, Electric |
| 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 | KGE |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-04 |
| Decision Date | 2009-06-26 |
| Summary: | summary |