FDA.reportPublic FDA data

Endolumik

Primary DI
G461EGCT36M0
Brand
Endolumik
Company
Endolumik, Inc.
Model
EGCT36M
Device description
36F Endolumik Gastric Calibration Tube, M Series
Published
2024-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyGastroenterology, Urology2
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240069000Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)Endolumik2024-02-08KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G461EGCT36M1PackageHIBCC5In Commercial Distribution
G461EGCT36M0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gastric calibration tubeA thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure500 KiloPascal1060 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-18 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
304-207-0072customerservice@endolumik.com

Regulatory Flags#

DUNS number
117601339
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G461CEGCT40M0EndolumikCEGCT40M2026-08-25
G461EGCT40M0EndolumikEGCT40M2024-08-06
G461EGCT36M1EndolumikEGCT36M2024-08-06
G461EGCT40M1EndolumikEGCT40M2024-08-06
G461EGCT360EndolumikEGCT362023-05-15
G461EGCT361EndolumikEGCT362023-05-15
G461EGCT400EndolumikEGCT402023-05-15

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