Clear-Jet Injection Catheter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Clear-Jet Injection Catheter EUDAMED
- Device Name
- Single-Use Endoscopic Injection Catheter EUDAMED
- Model / Reference
- FM-EI0002(1800)(0.05T)C EUDAMEDFM-EI0002(2300)(0.08T)C EUDAMEDFM-EI0002(I2)(1800)(0.08T)C EUDAMEDFM-EI0002(1800)(0.08T)C EUDAMEDFM-EI0005(I2)(1800)(0.1T)C EUDAMEDFM-EI0001(I2)(1800)(0.1T)C EUDAMEDFM-EI0005(1800)(0.1T)C EUDAMEDFM-EI0002(I2)(2300)(0.08T)C EUDAMEDFM-EI0001(I2)(2300)(0.05T)C EUDAMEDFM-EI0001(I2)(2300)(0.08T)C EUDAMEDFM-EI0002(I2)(1800)(0.05T)C EUDAMEDFM-EI0002(I2)(1800)(0.1T)C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809327357888 EUDAMED08809327355693 EUDAMED08809327355624 EUDAMED08809327357871 EUDAMED08809327355600 EUDAMED08809327357956 EUDAMED08809327357895 EUDAMED08809327355655 EUDAMED08809327357925 EUDAMED08809327357949 EUDAMED08809327355648 EUDAMED08809327355631 EUDAMED
- Basic UDI-DI
- 0880932735EIGB EUDAMED
- 510(k) Number
- K181690 FDA 510(k)
- FDA Product Code
- FBK FDA 510(k)
- EMDN Code
- K0199 ENDOTHERAPY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Market of Registration
- Greece EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Clear-Jet Injection Catheter is an Endoscopic Injection Needle, designed for precise fluid delivery during endoscopic procedures. It facilitates the injection of substances such as sclerosing agents, contrast media, or therapeutic solutions into targeted tissues, aiding in interventions like variceal treatment or biliary drainage. Its transparent design allows real-time visualization of fluid flow, enhancing procedural accuracy and safety.
This catheter is supplied as a single-use, non-sterile device intended for use in controlled clinical settings such as endoscopy suites or urology labs. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance and MDR authorization. Available in various sizes and configurations, it must be sterilized by the user prior to use if required for sterile procedures. Compatibility with MRI environments is not specified, and proper handling, storage, and disposal per manufacturer guidelines are essential.
Frequently asked questions
What types of procedures is the Clear-Jet Injection Catheter primarily used for, and why is its transparent design beneficial?
The Clear-Jet Injection Catheter is designed for endoscopic procedures where precise fluid delivery is required, such as variceal treatment or biliary drainage. Its transparent design allows clinicians to visualize the flow of injected substances in real-time, which enhances procedural accuracy and reduces the risk of misplacement or leakage, thereby improving safety and effectiveness.
Is the Clear-Jet Injection Catheter intended for single-use or reusable applications, and what does this mean for my workflow?
The Clear-Jet Injection Catheter is explicitly labeled as a single-use device, meaning it is intended for one-time use only. This design choice reduces the risk of cross-contamination and ensures sterility for each procedure. If sterile conditions are required for your procedure, you must sterilize the device yourself prior to use, as it is supplied in a non-sterile state.
What sizes or configurations are available for the Clear-Jet Injection Catheter, and how do I determine the right one for my patient?
The Clear-Jet Injection Catheter is available in various sizes and configurations, though the exact specifications are not detailed in the provided data. To determine the appropriate size, consult the manufacturer’s guidelines or technical documentation, which likely align with the anatomical or procedural requirements (e.g., needle gauge, length, or tip design) for your specific application in gastroenterology or urology.
How should the Clear-Jet Injection Catheter be stored, and are there any special handling instructions I should follow?
The Clear-Jet Injection Catheter must be stored and handled according to the manufacturer’s guidelines to maintain its integrity and functionality. Since it is non-sterile as supplied, ensure it is kept in a clean, dry environment away from direct sunlight or extreme temperatures. If sterilization is required before use, follow the specified sterilization method (e.g., autoclave, ethylene oxide) to avoid damaging the device. Improper storage or handling could compromise its performance or safety.
What regulatory pathways has the Clear-Jet Injection Catheter followed, and how does this affect its use in clinical settings?
The Clear-Jet Injection Catheter has received FDA 510(k) clearance and MDR authorization, indicating it has undergone regulatory review to demonstrate substantial equivalence to predicate devices and compliance with European medical device regulations. This means it is legally marketable in the U.S. and EU for its intended uses in gastroenterology and urology procedures, but clinicians should always verify compliance with local regulations and institutional policies before use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181690 | Class II | Active |
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Manufacturer
- Manufacturer
- Finemedix Co., Ltd.
Sources (13)
- FDA 510(k) K181690 24 fields · synced Sep 18, 2026
- EUDAMED e4abbca8-37de-4b11-9e4c-e48026161f20 61 fields · synced Jun 20, 2026
- EUDAMED 6db09a0d-13e7-4602-95a8-bfee8027c9d7 61 fields · synced Jul 10, 2026
- EUDAMED 16ced187-794b-442e-baa3-ae594ffa0e78 61 fields · synced Jul 10, 2026
- EUDAMED 30c4fe81-c176-425f-87c0-5c66580fe6b7 61 fields · synced Jul 11, 2026
- EUDAMED 901f86af-cc99-40e0-8539-7c99df818dce 61 fields · synced Jul 12, 2026
- EUDAMED 541c53ad-7a75-4e0f-b572-0a37e9157649 61 fields · synced Jul 14, 2026
- EUDAMED 9f11a228-e23f-4f68-a4de-87e4b1e110e1 61 fields · synced Jul 15, 2026
- EUDAMED 0b2373c4-cd75-4be1-967c-ca325f48a082 61 fields · synced Jul 16, 2026
- EUDAMED cb884bd8-dac0-45df-b7a5-cda9a4329193 61 fields · synced Jul 22, 2026
- EUDAMED a9517ee9-1f69-4222-abf1-6d19efbdec39 61 fields · synced Jul 25, 2026
- EUDAMED d30bd9b8-42c2-42cc-a58d-54395853d059 61 fields · synced Jul 29, 2026
- EUDAMED 03979100-1dfd-4e0d-bea0-e1a3de410c06 61 fields · synced Jul 29, 2026