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# FDA Clears UVision 360 Luminelle 360 Bx Sheath
- URL: https://www.fdaweb.com/fda-clears-uvision-360-luminelle-360-bx-sheath/
- Published: 2021-07-07T12:00:00.000Z
- Updated: 2026-09-14T17:05:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149661

FDA has cleared the UVision 360 Luminelle Bx (biopsy) sheath, expanding the capability of the Luminelle DTx system. The company [says](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=&cad=rja&uact=8&ved=2ahUKEwiGp-v229HxAhUJVc0KHbwdANEQxfQBMAB6BAgLEAM&url=https%3A%2F%2Fwww.prnewswire.com%2Fnews-releases%2Fus-food-and-drug-administration-clears-uvision360-inc-novel-luminelle-360-bx-biopsy-sheath-301326558.html&usg=AOvVaw2YwbIf%5F0K7iEqKr4B6e5I5) the sheath, combined with the DTx system, is the first and only integrated directed biopsy device not requiring the use of additional instruments and indicated for uterine and bladder biopsies.

The Luminelle DTx system is described as an endoscopic platform assisting both male and female procedures. The system is cleared by FDA for both diagnostic and operative hysteroscopy and cystoscopy.