Semi-automatic Biopsy-Needle (BIM 18/20) +8 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222462 FDA 510(k)
- FDA Product Code
- KNW FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1075 FDA 510(k)
- Regulation Number
- 876.1075 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Semi-Automatic Biopsy-Needle is a spring-loaded, percutaneous biopsy device designed for obtaining soft-tissue samples from organs such as the breast, kidney, liver, and prostate. Classified under product code KNW, it is intended for use in diagnostic procedures requiring tissue acquisition for histopathological examination.
This device is supplied as a sterile, single-use system comprising a handle, stylet, trigger, and coring guide. It operates via manual insertion followed by activation of the spring-loaded mechanism to retrieve tissue samples. Authorized under FDA 510K clearance and MDR compliance, the device is intended for use in clinical settings and must be handled in accordance with standard aseptic techniques. Each model variant (e.g., BIM 18/20, BIM 14/10) denotes specific gauge or length configurations.
Frequently asked questions
What types of tissues or organs is this biopsy needle designed to sample, and how does the spring-loaded mechanism work in the procedure?
This semi-automatic biopsy needle is specifically designed for obtaining soft-tissue samples from organs like the breast, kidney, liver, and prostate. The spring-loaded mechanism allows for percutaneous insertion of the needle into the target tissue, followed by activation of the trigger to automatically retrieve the sample. This ensures consistent and controlled tissue acquisition for histopathological examination.
Are these biopsy needles single-use or reusable, and what components make up the system?
These biopsy needles are intended for single-use only. Each system includes a sterile handle, stylet, trigger, and coring guide, all packaged together to maintain sterility and prevent cross-contamination between procedures.
What are the different model variants available, and how do the numbers in the model names (e.g., BIM 18/20) relate to the device specifications?
The model variants (e.g., BIM 18/20, BIM 14/10) correspond to specific gauge and length configurations. The first number (e.g., 18, 16, or 14) likely represents the gauge, while the second number (e.g., 20, 15, or 10) indicates the length in centimeters or another standardized unit, allowing clinicians to select the appropriate size for their procedure.
How should these biopsy needles be stored, and what precautions should be taken to ensure their integrity before use?
Since these devices are sterile and single-use, they should be stored in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediately before use to preserve sterility and prevent contamination.
What regulatory pathways have been followed for this device, and which advisory committees were involved in the review process?
This device has undergone review through the FDA’s 510(k) clearance process and complies with the Medical Device Regulation (MDR). The review was conducted under the Gastroenterology and Urology advisory committees, specifically the Subcommittee on Urology (SU), to assess its safety and effectiveness for diagnostic biopsy procedures.
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: Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle ..., Semi-automatic Biopsy-Needle BIM 18/20 - fda.report, AccessGUDID - DEVICE: Semi-automatic Biopsy-Needle BIM 18/20 ..., Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle ...
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 | K222462 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ITP Innovative Tomography Products GmbH
Sources (2)
- FDA 510(k) K222462 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026