Disposable Endoscope Injection Needle
by Yangzhou Fartley Medical Instrument Technology Co., Ltd
510(k) K220292
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK220292 | Date19 Aug 2022 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- FBK
- FDA applicant
- Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Disposable Endoscope Injection Needle is a single-use medical device classified as an Endoscopic Injection Needle, designed for use in endoscopic procedures. It facilitates the precise injection of fluids or substances into tissues during gastrointestinal or urological examinations, aiding in diagnostic or therapeutic interventions such as biopsies, sclerotherapy, or lesion treatment.
This device is intended for single-use only and is supplied sterile in a disposable packaging. It is regulated under the FDA 510(k) clearance and MDR (Medical Device Regulation), with a classification as a Class II device. The needle is compatible with standard endoscope channels and must be handled in accordance with aseptic techniques to ensure sterility and safety. No MRI safety information is provided, and storage should follow manufacturer guidelines to maintain integrity.
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Questions
AI-generated answers, 18 Sep 2026
What types of medical procedures is this disposable endoscope injection needle designed to assist with?
This device is specifically designed for use during endoscopic procedures in gastroenterology and urology, such as biopsies, sclerotherapy, or lesion treatment. It facilitates the precise injection of fluids or substances into tissues during examinations, aiding both diagnostic and therapeutic interventions.
Is this needle reusable, or is it intended for single-use only?
The device is explicitly labeled for single-use only. It is supplied sterile in disposable packaging, and reuse is not recommended to maintain safety and sterility standards.
How should I store this needle to ensure it remains effective?
Storage instructions are not detailed in the provided data, but the manufacturer recommends following their guidelines to maintain the needle’s integrity. Since it is sterile and single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use.
What regulatory pathways has this device undergone, and what does that mean for its use?
The device has been cleared under the FDA 510(k) pathway and complies with the EU Medical Device Regulation (MDR). It is classified as a Class II device, meaning it has undergone rigorous review by regulatory authorities to ensure safety and performance for its intended use in endoscopic procedures.
Can this needle be used with any standard endoscope, or are there compatibility concerns?
The device is designed to be compatible with standard endoscope channels, but compatibility may depend on the specific endoscope model. Always verify with the manufacturer or endoscope manufacturer to ensure proper fit and functionality before use.