The following data is part of a premarket notification filed by Nelis with the FDA for Endo Keeper.
| Device ID | K152598 |
| 510k Number | K152598 |
| Device Name: | Endo Keeper |
| Classification | Laparoscopic Single Port Access Device |
| Applicant | NELIS 1005,201-DOUG BUCHEON TECHNO PARL SSANGYONG3CHA SAMJEONG-DONG OJEONG-GU Bucheon, KR 421-742 |
| Contact | Seo Ou Nam |
| Correspondent | Peter Chung PLUS GLOBAL 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | OTJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-11 |
| Decision Date | 2016-03-17 |
| Summary: | summary |