Device Dossier
PDS II™ Endoloop ™ 45cm - Suture, polydioxanone
Device Dossier for PDS II™ Endoloop ™ 45cm - Suture, polydioxanone (Suture, polydioxanone, Class III, sponsor Johnson & Johnson Medical). ARTG record,…
- GMDN category: Suture, polydioxanone
Intended purpose
PDS II sutures are intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. The Endoloop ligature is for use in endoscopic suturing and knot tying. It can be used in any type of endoscopic procedure using sutures or ligatures and enable extracorporeal and intracorporeal knots to be tied.
Functional description
Endoloop is a single-use medical device used in endoscopic procedures. It includes a plastic tube (made of Nylon 12, length 30.5cm) that is narrowed on one end and scored on the other. A length of suture is formed into a ligature loop with a knot which becomes secure when the device is activated. The opposite end of the suture is fastened to the scored end, which acts as a handle. The PDS II suture is a sterile, synthetic, absorbable monofilament suture made from polyester poly (p-dioxanone).