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# FDA Clears Lumendi 510(k) for Endoscopic Scissors
- URL: https://www.fdaweb.com/fda-clears-lumendi-510-k-for-endoscopic-scissors/
- Published: 2018-05-29T12:00:00.000Z
- Updated: 2026-09-15T00:08:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141547

FDA has cleared a Lumendi 510(k) for the DiLumen Is Endolumenal Interventional Scissors, a sterile, single-use, disposable, monopolar electrosurgical device for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. “Adequate tissue manipulation and traction, combined with effective cutting, dissecting and cauterizing, continues to be a major challenge for therapeutic procedures in the digestive tract,” the company says. The device comprises a single-use, soft flexible sheath that fits over standard and small-diameter endoscopes. It is designed to employ two balloons, one behind the bending section of the endoscope and the second that can extend in front of the tip of the endoscope once at the lesion site, the company says. “When both balloons are deployed and inflated, a stable Therapeutic Zone (TZ) is created,” it says. “This TZ facilitates more localized insufflation and manipulation of the colon and may provide better access to lesions.”