The following data is part of a premarket notification filed by Xenocor, Inc with the FDA for Saberscope5 Laparoscope.
| Device ID | K220872 |
| 510k Number | K220872 |
| Device Name: | Saberscope5 Laparoscope |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Xenocor, Inc 350 E. 400 S., Suite 401 Salt Lake City, UT 84111 |
| Contact | Evan Kelso |
| Correspondent | Spencer Walker Peak Regulatory Consulting, LLC 370 S. 300 E. Salt Lake City, UT 84111 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-25 |
| Decision Date | 2022-04-20 |