FDA clearance and bench testing for the Utepreva sampler. What each one covers.
One procedure.
Three ways to collect.
Watch how three complementary mechanisms work together to support effective tissue collection.
What the evidence is.
Every figure in this section names its source.
FDA cleared the Utepreva Endometrial Sampler (UP01) in August 2024 under 510(k) K240595, finding it substantially equivalent to the predicate device, the Tao Brush I.U.M.C. Endometrial Sampler (K170603, Cook Incorporated). The submission compared the two devices and included non-clinical performance testing: biocompatibility, visual and dimensional inspection, tensile strength, torque, bristle retention, fluid retention and fluid transfer. The 510(k) did not include a clinical study.1
Bench testing
In bench testing, the mean weight of simulated tissue captured by the Utepreva brush and tip was 67% higher than the mean for the Cook Medical Tao Brush. Sliced bovine liver, 22 test runs in each arm, p = 0.017. The Utepreva suction feature was not engaged for this comparison, and the comparator arm used 15 Tao Brush devices, 7 of them cleaned and run a second time. This testing was carried out in March 2025, after the August 2024 clearance, and was not part of FDA’s review of K240595. Bench testing is not a clinical study and it does not measure diagnostic performance or sample adequacy in patients.2
In the same testing, tissue was observed along the majority of the brush length. This is an observation from images, not a measurement.2
Tao Brush is a trademark of Cook Incorporated. Utepreva, LLC is not affiliated with, endorsed by or sponsored by Cook Incorporated or Cook Medical.
From the cervix
to the preservative.
The sampler is gently inserted through the cervix into the uterus. A skirt on the sheath reaches the cervix and indicates when to stop inserting. The brush is extended until resistance is felt when the tip meets the fundus, and the device is rotated four or five full turns. The handle is then pulled back, withdrawing the brush and tip into the outer sheath. Brush, sponge and any aspirated fluid go into preservative solution for the pathology lab.
Full directions, contraindications, precautions and adverse reactions are in the Instructions for Use supplied with the device.
Take the documents with you.
Utepreva for your practice
See how it works. Request a demonstration for your practice.
Suction, brushing and absorption, in one endometrial sampler.
