FDA.reportPublic FDA data

Saberscope™ Articulating Laparoscope

Primary DI
00854490007045
Brand
Saberscope™ Articulating Laparoscope
Company
XENOCOR, INC.
Model
SAS-A-536L
Catalog number
SAS-A-536L
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.
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
GCQEndoscope, Flexible
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
GCQEndoscope, FlexibleGastroenterology, Urology2
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260177000Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)Xenocor, Inc.2026-02-12GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854490007042PackageGS15In Commercial Distribution
00854490007045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085449000704210854490007042
00854490007045008544900070458544900070450854490007045

GMDN Terms#

Term, Definition table
TermDefinition
Flexible-tip video laparoscope/thoracoscopeAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length36Centimeter
Outer Diameter5.4Millimeter

Contacts#

Phone, Email table
PhoneEmail
(844) 936-6267quality@xencor.com

Regulatory Flags#

DUNS number
080306345
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854490007052Saberscope™ Video Processing UnitVPUX-1VPUX-12026-04-20
00854490007007Xenoscope 0°XS-0-1036XS-0-10362024-12-17
00854490007014Xenoscope 30°XS-30-1036XS-30-10362024-12-17
00854490007038SaberscopeXSA-0-0536XSA-0-05362024-12-17
00854490007021XenoBoxXD-A1XD-A12024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422110MillenniumAvalign Technologies, Inc.GCJ2026-07-24
00198506091957ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092848ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
00198506092862ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-22
14026704645333WECKTELEFLEX INCORPORATEDGCJ2026-07-21
00198506092176ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-07-17
00888867561793Arthrex®ARTHREX, INC.GCJ2026-07-17
B382SD90781001000Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD9918100Surgical DirectSurgical Direct, Inc.GCJ2026-07-17
B382SD1184590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD12711090Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271390Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD1271590Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13018770Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD13168350Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD23373490Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD770561050Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775011530Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD775021630Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD77505650Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751586C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
B382SD7751587C0Surgical DirectSurgical Direct, Inc.GCJ2026-07-14
00850045863012ArthroFree® 2 ReceiverLazurite Holdings LLCGCJ2026-07-10
00850045863029ArthroFree® 2 Wireless Camera HeadLazurite Holdings LLCGCJ2026-07-10
00850045863036ArthroFree® 2 Operating Room KitLazurite Holdings LLCGCJ2026-07-10
00850045863043ArthroFree® 2 Single Camera Head SetLazurite Holdings LLCGCJ2026-07-10
B382SD883110450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
B382SD88324450Surgical DirectSurgical Direct, Inc.GCJ2026-07-10
00817401029178EndoplusEndoplusHET2026-07-08
00190776421731MillenniumAvalign Technologies, Inc.GCJ2026-06-24