FDA.reportPublic FDA data

Consumable Pack (Sheath, Obturator, Manifold & Camera Cover)

Primary DI
05060768280040
Brand
Consumable Pack (Sheath, Obturator, Manifold & Camera Cover)
Company
SURGEASE INNOVATIONS LIMITED
Model
LX1-CCS-202
Catalog number
LX1-CCS-202
Device description
Consumable Pack used with LumenEye X1
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FANSigmoidoscope, Rigid, Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FANSigmoidoscope, Rigid, ElectricalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232262000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232262000LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )Surgease Innovations Limited2023-11-30FAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060768280712PackageGS125In Commercial Distribution
05060768280040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060768280712050607682807125060768280712
05060768280040050607682800405060768280040

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope sheath, single-useA component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a single-use device.

Regulatory Flags#

DUNS number
221628713
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060768280231Consumable Pack (Sheath, Obturator & Manifold)LX1-CSB-201LX1-CSB-2012026-05-13
05060768280286LumenEye X1 ScopeLX1-SCP-203LX1-SCP-2032026-05-13
05060768280736Large LumenEye x1 Manifold -26mm LX1-LMB-261LX1-LMB-2612026-05-13
05060768280750Large LumenEye x1 Manifold -30mm LX1-LMB-301LX1-LMB-3012026-05-13
05060768280576SESISSIS-CSB-1012026-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060768280231Consumable Pack (Sheath, Obturator & Manifold)SURGEASE INNOVATIONS LIMITEDFAN2026-05-13
05060768280286LumenEye X1 ScopeSURGEASE INNOVATIONS LIMITEDFAN2026-05-13
05060768280736Large LumenEye x1 Manifold -26mm SURGEASE INNOVATIONS LIMITEDFAN2026-05-13
05060768280750Large LumenEye x1 Manifold -30mm SURGEASE INNOVATIONS LIMITEDFAN2026-05-13