The following data is part of a premarket notification filed by Xenocor, Inc with the FDA for Xenocor Xenoscope Laparoscopic System.
| Device ID | K161838 |
| 510k Number | K161838 |
| Device Name: | Xenocor Xenoscope Laparoscopic System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Xenocor, Inc 630 Komas Dr. Suite 200 Salt Lake City, UT 84108 |
| Contact | Spencer Walker |
| Correspondent | Spencer Walker Xenocor, Inc 630 Komas Dr. Suite 200 Salt Lake City, UT 84108 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2016-09-26 |
| Summary: | summary |