Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233294 FDA 510(k)
- FDA Product Code
- KNW FDA 510(k)
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 Automatic Biopsy Needle BAM and Semi-Automatic Needle BIM are core needle biopsy devices designed for the acquisition of tissue samples from soft tissues. These devices facilitate precise, controlled tissue extraction under imaging guidance, commonly used in diagnostic procedures for evaluating abnormalities such as tumors or lesions in organs like the prostate, liver, or kidney.
The needles are supplied sterile and intended for single-use, ensuring patient safety and procedural consistency. They are regulated under FDA 510(k) clearance and EU MDR compliance, with the Automatic Biopsy Needle BAM offering automated actuation for enhanced precision, while the Semi-Automatic Needle BIM requires manual trigger activation. Both are categorized under product code KNW and are intended for use in clinical settings such as radiology or urology departments.
Frequently asked questions
What is the key difference between the Automatic Biopsy Needle BAM and the Semi-Automatic Needle BIM in terms of how they are used during a procedure?
The Automatic Biopsy Needle BAM features automated actuation, meaning the needle’s firing mechanism is triggered electronically for precise, controlled tissue extraction. In contrast, the Semi-Automatic Needle BIM requires manual activation via a trigger, allowing the clinician to control the firing process. This distinction affects ease of use and procedural workflow, particularly in imaging-guided biopsies where consistency or adaptability may be preferred.
Are these biopsy needles reusable, or are they designed for single-use only? Why does this matter?
Both the Automatic Biopsy Needle BAM and the Semi-Automatic Needle BIM are explicitly supplied sterile and intended for single-use only. This design ensures patient safety by eliminating cross-contamination risks and maintains procedural consistency, as reuse could compromise sterility and device performance. Single-use also aligns with best practices for reducing infection risks in clinical settings like radiology or urology.
What types of tissues or organs are these needles commonly used to sample, and why are they suitable for those applications?
These needles are primarily designed for acquiring tissue samples from soft tissues, such as those found in organs like the prostate, liver, or kidney. Their core needle design allows for precise penetration and controlled extraction of small, core-like samples, which is ideal for diagnosing abnormalities like tumors or lesions. The controlled actuation (automatic or semi-automatic) ensures minimal tissue disruption, making them well-suited for imaging-guided procedures where accuracy and patient safety are critical.
How are these devices regulated, and what does that mean for clinicians or facilities considering them for purchase?
The Automatic Biopsy Needle BAM and Semi-Automatic Needle BIM are regulated under FDA 510(k) clearance and comply with EU MDR (Medical Device Regulation). This means they have undergone rigorous review by regulatory bodies to demonstrate safety and effectiveness, comparable to established devices (substantially equivalent under FDA). Clinicians or facilities can rely on their compliance for procedural consistency, while the regulatory route ensures adherence to international standards for medical devices in radiology or urology settings.
What should I consider when storing these biopsy needles before use, given their single-use and sterile nature?
Since these needles are sterile and single-use, they should be stored in their original, unopened packaging to preserve sterility until immediately before use. The packaging likely includes protective barriers to prevent contamination. Facilities should follow manufacturer guidelines for storage conditions (e.g., room temperature, away from direct sunlight) and ensure the needles are not exposed to moisture or physical damage. Proper storage is essential to maintain device integrity and patient safety.
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 | K233294 | Class II | Active |
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Manufacturer
- Manufacturer
- ITP Innovative Tomography Products GmbH
Sources (2)
- FDA 510(k) K233294 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 8, 2026