Biopsy needles
Themy
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.
Themy 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 |
|---|---|---|---|
| TYC1410 | Length 100 mm; Needle Gauge 14 G | MR Unsafe | Available |
| TYC1410 | Length 100 mm; Needle Gauge 14 G | MR Unsafe | Available |
| TYC1412 | Needle Gauge 14 G; Length 120 mm | MR Unsafe | Available |
| TYC1412 | Needle Gauge 14 G; Length 120 mm | MR Unsafe | Available |
| TYC1416 | Needle Gauge 14 G; Length 160 mm | MR Unsafe | Available |
| TYC1416 | Needle Gauge 14 G; Length 160 mm | MR Unsafe | Available |
| TYC1810 | Length 100 mm; Needle Gauge 18 G | MR Unsafe | Available |
| TYC1810 | Length 100 mm; Needle Gauge 18 G | MR Unsafe | Available |
| TYC1812 | Length 120 mm; Needle Gauge 18 G | MR Unsafe | Available |
| TYC1812 | Length 120 mm; Needle Gauge 18 G | MR Unsafe | Available |
| TYC1816 | Needle Gauge 18 G; Length 160 mm | MR Unsafe | Available |
| TYC1816 | Needle Gauge 18 G; Length 160 mm | MR Unsafe | Available |
| TYC1820 | Needle Gauge 18 G; Length 200 mm | MR Unsafe | Available |
| TYC1820 | Needle Gauge 18 G; Length 200 mm | MR Unsafe | Available |
| TYC1825 | Length 250 mm; Needle Gauge 18 G | MR Unsafe | Available |
| TYC1825 | Length 250 mm; Needle Gauge 18 G | MR Unsafe | Available |
| TYC2010 | Length 100 mm; Needle Gauge 20 G | MR Unsafe | Available |
| TYC2010 | Needle Gauge 20 G; Length 100 mm | MR Unsafe | Available |
| TYC2016 | Needle Gauge 20 G; Length 160 mm | MR Unsafe | Available |
| TYC2016 | Length 160 mm; Needle Gauge 20 G | MR Unsafe | Available |
| TYC2020 | Length 200 mm; Needle Gauge 20 G | MR Unsafe | Available |
| TYC2020 | Length 200 mm; Needle Gauge 20 G | MR Unsafe | Available |
FDA clearances
- 510(k) K160316 October 2016
Procedures that use biopsy needles
Frequently asked questions
What is Themy 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 Themy?
Themy is made by M.d.l. S.r.l.. It is listed under biopsy needles and systems in our device library.
What sizes does Themy come in?
Sizes listed for Themy: Length: 100–250 mm; Needle Gauge: 14–20 G. Confirm availability with the manufacturer's instructions for use.
Is Themy MRI safe?
The FDA device database lists Themy as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Themy FDA cleared?
Themy is covered by FDA submission K160316.
How do I contact a M.d.l. S.r.l. sales representative?
M.d.l. S.r.l. has not listed representatives on LA Vascular yet. Visit the M.d.l. S.r.l. 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.