Description
Disposable Transperineal Biopsy Needle Guide for Ultrasound-Guided Prostate Procedures
The transperineal biopsy needle guide is a probe-specific, single-use accessory that clips onto an endocavity ultrasound transducer and channels the needle through the perineum using the freehand technique. No brachytherapy grid is required. It is designed for urologists performing transperineal prostate biopsies and procedures under ultrasound guidance, using the freehand technique under local or general anesthesia.
Four probe-specific variants cover a broad range of endocavity transducers from BK, GE, Hitachi, Sonoscape, Terason, and Esaote. Each variant ships in a box of 10 individually wrapped sterile units.
Key Features
- Needle Gauge Compatibility: GTK151, GTK153, and GTK154 accept 15G-17G coaxial needles and 16G-18G biopsy needles. GTK150 is compatible with 15-16G needles.
- Body Material: Polycarbonate (GTK151, GTK153, GTK154) or ABS (GTK150). Latex-free, phthalate-free, no components of animal or biological origin.
- Sterility and Shelf Life: EtO (ethylene oxide) sterilized. Non-pyrogenic. 5-year shelf life from date of manufacture.
- MRI/US Fusion Support: Compatible with MR fusion-assisted biopsy workflows where pre-acquired MRI data is overlaid on live ultrasound. The device must not be placed inside an MRI scanner; it has not been evaluated for MRI safety or compatibility in that environment.
- Regulatory Clearance: FDA 510(k) cleared for the US market. EU Class IIa under MDR 2017/745, CE certified (Notified Body 1984).
- Storage Requirements: Dry location, 5-30°C (41-86°F), 30-70% relative humidity, away from direct sunlight. Check packaging integrity and expiration date before use.
Applications
- Transperineal Prostate Biopsy: Needle guidance for ultrasound-guided transperineal prostate biopsies, including MRI/US fusion-targeted procedures.
- Transperineal Prostate Procedures: Controlled needle access via the perineum under endocavity ultrasound guidance.
Available Models
| SKU | Compatible Probe(s) | Material | Needle Compatibility | Pack Size |
|---|---|---|---|---|
| GTK150 | BK 8848, BK 9048, BK 8818, BK E14C4t, BK 9018 | ABS | 15-16G | Box of 10 units |
| GTK151 | BK 8818, BK 9018 (E14C4t) | Polycarbonate | 15G-17G coaxial / 16G-18G biopsy | Box of 10 units |
| GTK153 | Hitachi C41L47RP, Hitachi U533 | Polycarbonate | 15G-17G coaxial / 16G-18G biopsy | Box of 10 units |
| GTK154 | GE ERB7, Sonoscape BCL10-5, Terason 8BP4, Esaote TRT33 | Polycarbonate | 15G-17G coaxial / 16G-18G biopsy | Box of 10 units |
Packaging Information
- Quantity: 10 individually packaged sterile units per box.
- Sterilization: EtO (ethylene oxide). Non-pyrogenic.
- Material: Polycarbonate (GTK151, GTK153, GTK154) or ABS (GTK150). Latex-free, phthalate-free, no animal-derived components.
- Shelf Life: 5 years from date of manufacture.
Frequently Asked Questions
Q: Which ultrasound probe models are compatible with these transperineal biopsy needle guides?
A: Four probe-specific variants cover the most common endocavity transducers used for transperineal procedures. GTK150 fits BK 8848, 9048, 8818, E14C4t, and 9018. GTK151 fits BK 8818 and 9018 (E14C4t). GTK153 fits Hitachi C41L47RP and U533. GTK154 fits GE ERB7, Sonoscape BCL10-5, Terason 8BP4, and Esaote TRT33. Contact us if your probe model is not listed.
Q: What needle gauge sizes work with the transperineal biopsy guide?
A: GTK151, GTK153, and GTK154 accept 15G-17G coaxial needles and 16G-18G biopsy needles. GTK150 is compatible with 15-16G needles. Always verify gauge compatibility with the specific needle before the procedure.
Q: Are these needle guides compatible with MRI/ultrasound fusion biopsy systems?
A: Yes. The guides support MR fusion-assisted biopsy workflows, where pre-acquired MRI images are overlaid on live ultrasound for targeted needle placement. The device must not be used inside an MRI scanner; it has not been evaluated for MRI safety or compatibility in that setting.
Q: What is the advantage of the transperineal approach over the transrectal approach?
A: The transperineal approach avoids passing the needle through the rectal wall, removing the risk of introducing fecal bacteria into the procedure field. It also provides better access to the anterior zone of the prostate, which is difficult to reach via the transrectal route.
For additional assistance, please contact our knowledgeable sales team at +1 (877) 220-4567 or use the live chat feature on our website.
Payment & Security
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EDM Medical Solutions is a premier supplier and manufacturer of medical imaging products, including ultrasound supplies, surgical drapes, and needle guides. We are committed to delivering a high-quality and cost-effective range of products that enhance patient care and operational efficiency.
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By prioritizing customer satisfaction and maintaining excellent service standards, EDM continues to be the partner of choice for facilities across clinical areas, including ASCs, imaging centers, and Ob/Gyn practices.
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