The following data is part of a premarket notification filed by Xenocor, Inc with the FDA for Xenocor Articulating Xenoscope Laparoscope.
| Device ID | K193315 |
| 510k Number | K193315 |
| Device Name: | Xenocor Articulating Xenoscope Laparoscope |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Xenocor, Inc 630 Komas Dr. Suite 200 Salt Lake City, UT 84108 |
| Contact | Evan Kelso |
| Correspondent | Spencer Walker University Of Utah 10 North 1900 East, EHSL Rm, 22B Salt Lake City, UT 84112 |
| Product Code | GCJ |
| Subsequent Product Code | GCQ |
| Subsequent Product Code | HET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-29 |
| Decision Date | 2020-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854490007038 | K193315 | 000 |