The following data is part of a premarket notification filed by Nelis with the FDA for Glove Port.
| Device ID | K141715 |
| 510k Number | K141715 |
| Device Name: | GLOVE PORT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NELIS 300 ATWOOD Pittsburgh, PA 15213 |
| Contact | Peter Chung |
| Correspondent | Peter Chung NELIS 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-25 |
| Decision Date | 2015-03-25 |
| Summary: | summary |