Saberscope™ Articulating Laparoscope

Basic Information

• Brand Name: Saberscope™ Articulating Laparoscope
• Primary DI: 00854490007045
• Version / Model: SAS-A-536L
• Catalog Number: SAS-A-536L
• Company Name: XENOCOR, INC.
• Labeler DUNS: 080306345
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-20
• Public Version: 1
• Public Version Date: 2026-04-28
• Public Version Status: New
• Public Device Record Key: 34341bbc-2e75-447e-95d8-04b3d744bb76

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.1720	2
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2
GCQ	Endoscope, Flexible	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
67489	Flexible-tip video laparoscope/thoracoscope	An electronic endoscope with a flexible distal tip intended for the visual examination and treatment of both the abdominal/retroperitoneal cavity and the thoracic cavity (i.e., intended for both anatomies). It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy and in the chest wall during thoracoscopy. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. The abdominal wall is distended providing space to allow the surgeon to directly view and/or operate on the exposed organs. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854490007045	GS1
Package	10854490007042	GS1	CASE	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K260177	000

Device Sizes

Type	Value	Unit	Text
Length	36	Centimeter
Outer Diameter	5.4	Millimeter