Device typeEndoscopic suturing unit, single-use: A sterile, manually-operated device intended to be used in combination with a compatible flexible endoscope (e.g., gastroscope, laparoscope) to mechanically approximate the edges of an internal wound or incision with sutures, typically during a gastrointestinal (GI) procedure. It is typically loaded with a needle/suture assembly and attached to the working end, or inserted through the working channel, of the endoscope. The device will also knot and cut the sutures as they are stitched; some types may also carry and/or knot a ligature. This is a single-use device.
FDA categoryEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Device ID00810275013052
Catalog numberR2375
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Safe
Size7.5mm