Biopsy needles
Semi-automatic Biopsy Needle - BIM16/15i
by ITP Innovative Tomography Products GmbH
A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.
Semi-automatic Biopsy Needle - BIM16/15i models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| BIM16/15i | Length 150 mm; Needle Gauge 16 G | MR Conditional | Available |
FDA clearances
- 510(k) K233294 June 2024
Procedures that use biopsy needles
Frequently asked questions
What is Semi-automatic Biopsy Needle - BIM16/15i used for?
A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.
Who makes Semi-automatic Biopsy Needle - BIM16/15i?
Semi-automatic Biopsy Needle - BIM16/15i is made by ITP Innovative Tomography Products GmbH. It is listed under biopsy needles and systems in our device library.
What sizes does Semi-automatic Biopsy Needle - BIM16/15i come in?
Sizes listed for Semi-automatic Biopsy Needle - BIM16/15i: Length: 150 mm; Needle Gauge: 16 G. Confirm availability with the manufacturer's instructions for use.
Is Semi-automatic Biopsy Needle - BIM16/15i MRI safe?
The FDA device database lists Semi-automatic Biopsy Needle - BIM16/15i as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Semi-automatic Biopsy Needle - BIM16/15i FDA cleared?
Semi-automatic Biopsy Needle - BIM16/15i is covered by FDA submission K233294.
How do I contact a ITP Innovative Tomography Products GmbH sales representative?
ITP Innovative Tomography Products GmbH has not listed representatives on LA Vascular yet. Visit the ITP Innovative Tomography Products GmbH company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.