Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)— 510(k) K260177
Substantially EquivalentXenocor, Inc.
FDA 510(k) clearance K260177 for Saberscope Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1), Substantially Equivalent on 2026-02-12. Applicant: Xenocor, Inc.. Device class: 2.
Summary
Xenocor lists the Saberscope Laparoscope (SAS-A-536L) and the Xenocor® Video Processing Unit (VPUX-1) under product code GCJ (Laparoscope, General & Plastic Surgery). The record doesn't describe either one beyond its name.
Class II, 21 CFR 876.1500. The General, Plastic Surgery review panel handled it as a Special 510(k), though the record lists Gastroenterology, Urology as the classification panel.
Xenocor filed from Salt Lake City, Utah. The substantially equivalent decision came 22 calendar days after receipt (January 21 to February 12, 2026).
Clearance details
- Applicant
- Xenocor, Inc.
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Recent devices under product code GCJ
view allMore clearances from Xenocor, Inc.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.