EndoClot

Basic Information

• Brand Name: EndoClot
• Primary DI: 16972011720219
• Version / Model: SIS-30
• Catalog Number: SIS-30
• Company Name: EndoClot Plus Co.,Ltd.
• Labeler DUNS: 544357082
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-10
• Public Version: 2
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: c7d8495c-eef3-4afb-ae11-8d26283b84d2

Device Description

EndoClot Submucosal Injection System EndoClot® Submucosal Injection Agent is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
PLL	Submucosal Injection Agent	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62217	Submucosal lift solution/gel	A sterile solution intended to be injected via an endoscopic injection needle into the submucosal layer of the gastrointestinal tract to facilitate excision of mucosal lesions (e.g., polyps, adenomas, early cancers) by lifting the mucosa over a bubble of fluid. It is typically a gel-like emulsion (e.g., containing fats and/or salts), and may include a dye. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26972011720216	GS1	Shelf Box	5	In Commercial Distribution
Primary	16972011720219	GS1

Premarket Submissions

Submission Number	Supplement Number
K191254	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 3 – 33 Degrees Celsius