Themy

Device typeEnd-cut biopsy gun handpiece/needle: 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.

FDA categoryBiopsy Needle, Instrument, Biopsy

Device ID08056138586833

Catalog numberTYC1416

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyMR Unsafe

Needle Gauge14 Gauge

Length160 Millimeter