USGI Medical, Inc.

Click Here To EMAIL INQUIRY
Web: http://www.usgimedical.com
E-Mail:
Address: 1140 Calle Cordillera, San Clemente, California 92673, USA
Phone: +1-(949)-369-3890 | Fax: +1-(949)-369-3891 | Map/Directions >>

Profile: USGI Medical, Inc. develops technologies & tools to surgeons and gastroenterologists to enable incisionless surgery, by providing surgeons the operating platform and specialized tools they need to perform surgery through a patient's mouth or other natural orifices, reducing the need for external incisions into the abdomen. Our incisionless operating platform includes the TransPort™ multi-lumen platform, the g-Prox® grasping / tissue approximation device, g-Cath™ tissue anchor delivery catheters and a variety of endosurgical tissue graspers.

FDA Registration Number: 3004447686

9 Products/Services (Click for related suppliers)

• Endoscope Accessories (FDA Code: KOG)

• Endoscopic Access Overtube (FDA Code: FED / 876.1500)

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Endoscopic Contamination Prevention Sheath (FDA Code: ODB / 876.1500)

• Expandable Tissue Anchors

• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720)

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

• Helical Endoscopic Tissue Graspers

• Implantable Staple (FDA Code: GDW / 878.4750)

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT / 878.5000)

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

• Tissue Approximation Systems