Identifiers
- 510(k) Number
- K030451 FDA 510(k)
- FDA Product Code
- FBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an Endoscopic Injection Needle, designed for the precise delivery of injectable materials into tissues during endoscopic procedures. It is classified under the Gastroenterology-Urology specialty and is intended for use with existing endoscopes to facilitate controlled tissue injection, enhancing procedural accuracy and patient outcomes.
The Injection Needle is supplied as a single-use, sterile device, intended for use in clinical settings such as cystoscopic procedures. It features a female-specific anatomical design, a rotational locking collar, and dual non-rotational needle ports for improved precision. Authorized under FDA 510(k) clearance (K030451), it adheres to regulatory standards for Class II medical devices (21 CFR 876.1500) and is not third-party reviewed.
Frequently asked questions
What types of endoscopic procedures is this injection needle designed for, and how does it improve precision during those procedures?
This Endoscopic Injection Needle is specifically designed for use in cystoscopic procedures within the Gastroenterology-Urology specialty. Its female-specific anatomical design, rotational locking collar, and dual non-rotational needle ports enhance procedural accuracy by allowing controlled delivery of injectable materials into tissues. These features help clinicians achieve better precision during injections, reducing the risk of misplacement and improving patient outcomes.
Is this needle reusable, or is it intended for single-use only? How does this affect clinical workflow?
The device is explicitly labeled as a single-use, sterile needle, meaning it is intended for one-time use only in clinical settings. This design choice eliminates the need for reprocessing, reducing the risk of contamination and ensuring consistent sterility for each patient. Clinicians can simply discard the needle after use, streamlining workflow and adhering to infection control protocols.
What storage conditions should be followed to maintain the needle’s sterility and functionality?
Since the needle is sterile and single-use, it should be stored in its original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment, protected from extreme temperatures, moisture, and direct sunlight. Avoid exposing it to sources of contamination or physical damage, as this could compromise its integrity before use.
How is this needle compatible with existing endoscopes, and does it require any special preparation before use?
The needle is intended for use with existing endoscopes within the Gastroenterology-Urology specialty, though compatibility depends on the specific endoscope model. No special preparation is mentioned in the device description, but clinicians should verify compatibility with their equipment beforehand. The female-specific anatomical design and rotational locking collar are key features that facilitate secure attachment to the endoscope’s interface.
What regulatory pathway was followed for this device’s approval, and what does that mean for its safety and performance?
This needle was cleared through the FDA 510(k) pathway, specifically under Traditional Review and classified as Substantially Equivalent (SE) to a predicate device. It adheres to 21 CFR 876.1500 for Class II medical devices, meaning it underwent rigorous evaluation to ensure safety, effectiveness, and performance. The Gastroenterology-Urology (GU) Advisory Committee reviewed the submission, though the device is not third-party reviewed, indicating direct FDA assessment of its design and intended 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. Sources consulted: Home - Carbon Medical Technologies, FDA Browser - Cleared 510 (K) - CARBON MEDICAL TECHNOLOGIES INJECTION ..., CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE 510 (k)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030451 | Class II | Active |
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Manufacturer
- Manufacturer
- Carbon Medical Technologies, Inc.
Sources (1)
- FDA 510(k) K030451 24 fields · synced Sep 19, 2026