Sutura Inc.

Address: 17080 Newhope St., Fountain Valley, California 92708, USA
Phone: +1-(714)-437-9801, 800-884-8550 | Fax: +1-(714)-437-9806 | Map/Directions >>

Profile: Sutura Inc. offers a line of minimally invasive vessel closure devices to suture the puncture created in the femoral artery during catheter-based procedures, primarily in the fields of cardiology & radiology. Our SuperStitch® line of products is used in connection with cardiovascular and vascular procedures that require a puncture or incision to the artery. It is designed for use with or without an access device depending on the endoscopic technique, for use during minimally invasive surgical procedures, fluoroscopically-guided procedures, or in an open setting.

The company has revenues of USD 10-25 Million, has ~40 employees and is ISO 9001 certified.

FDA Registration Number: 2031768

17 Products/Services (Click for related suppliers)  
• Aortic Punches
• Aortic Punches Tip Conical
• Cardiac Bypass Assist Tools, Anastomosis Assist Aortic Punch
• Chromic Sutures
• Cranial Sutures
• Dexon Sutures
• Disposable Aortic Punch
• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 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.
• General Sutures/Needles
• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• Medical Sutures
• 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.
• Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW / 878.5010)
Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.
• Reusable Aortic Punch
• Rotating Aortic Punch
• Single use Aortic Punch
• Single Use Suture Placement Devices

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