FDA 510(k) K220872, Saberscope5 Laparoscope, by Xenocor, Inc.
FDA 510(k) K220872, Saberscope5 Laparoscope, by Xenocor, Inc.
| 510(k) Number | K220872 |
| Device Classification Name | Laparoscope, General & Plastic Surgery |
| Device Name | Saberscope5 Laparoscope |
| Applicant | Xenocor, Inc. 350 E. 400 S., Suite 401 Salt Lake City, UT 84111 |
| Regulation Number | 876.15 |
| Classification Product Code | GCJ |
| Date Received | 03/25/2022 |
| Decision Date | 04/20/2022 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Gastroenterology/Urology |
| 510k Review Panel | General & Plastic Surgery |
| Type | Special |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 103 |
| Redacted Pages | 15 |
| Unredacted Pages | 88 |
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