Lumendi receives FDA 510(k) clearance for new interventional scissors: 4 things to know

Lumendi received FDA 510(k) clearance for the DiLumen Is Endolumenal Interventional Scissors.

Here are four things to know.

1. The scissors are a sterile, single-use, disposable, monopolar electrosurgical device for cutting, dissecting and cauterizing tissue in the digestive tract during endoscopic procedures.

2. This device and Lumendi's recently FDA-approved DiLumen C2 will round out the DiLumen platform of devices intended to improve access to the colon and reduce the need for surgical intervention.

3. The DiLumen C2 is a second-generation Endolumenal Interventional Platform intended to provide complete positioning of an endoscope in the large intestine. The EIP consists of a single-use sheath designed to fit over standard and small-diameter endoscopes.

4. Other DiLumen accessories include:

  • The Ig Endolumenal Interventional Grasper, an endoscopic tool designed to grasp and manipulate tissue within the digestive tract under direct endoscopic visualization
  • The Im Endolumenal Intervention Mount, a workstation designed to support the various accessories and allow the provider to perform procedures in a standing or seated position

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