FDA.reportPublic FDA data

XENOCOR, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30134451473013445147XENOCOR, INC.1N2026-01-01515 S 700 E, STE 3E Salt Lake City UT US 84102

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00854490007045Saberscope™ Articulating Laparoscope - The Saberscope™ is a single use, disposable laparoscope that provides illumination and High-Definition visualization for diagnostic & therapeutic procedures during laparoscopic surgery. The distal tip of the Saberscope™ can be moved or articulated + 90o providing the flexibility to obtain a wider range of views of patient anatomy. The camera and LED lights mounted at the distal, articulating end for improved visualization. Saberscope™ is designed for use with a 5mm (or larger) trocar.(844) 936-6267quality@xencor.com
00854490007052Saberscope™ Video Processing Unit - The Saberscope™ Video Processing Unit (VPU) connects to the Saberscope™ and video display monitor(s).The VPU can connect to up to 4 HDMI outputs.Users can record images and video to a USB drive via the front panel USB port.(844) 936-6267quality@xencor.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2026261269680587K260177Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)GCJ2026-02-12
2026261699243512K220872Saberscope5 LaparoscopeGCJ2022-04-20
2026261348430727K193315Xenocor Articulating Xenoscope LaparoscopeGCJ2020-01-27
2026261122347611K171344Xenocor Xenoscope Laparoscopic SystemGCJ2017-06-01
2026262018438263K161838Xenocor Xenoscope Laparoscopic SystemGCJ2016-09-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ52026-02-12

PMN#

GUDID#

Saberscope™ Articulating Laparoscope - The Saberscope™ is a single use, disposable laparoscope that provides illumination and High-Definition visualization for diagnostic & therapeutic procedures during laparoscopic surgery. The distal tip of the Saberscope™ can be moved or articulated + 90o providing the flexibility to obtain a wider range of views of patient anatomy. The camera and LED lights mounted at the distal, articulating end for improved visualization. Saberscope™ is designed for use with a 5mm (or larger) trocar.

XENOCOR, INC.

2026-04-20