Profile: Safestitch Medical develops a prototype for a plainly invasive obesity procedure to build up numerous devices in the areas of bariatric surgery, reflux interventions, barrett's esophagus, hernia repairs and in endoscopic surgery. Our product line comprises of intraluminal gastroplasty device - obesity, intraluminal gastroplasty device gerd, barrett's excision device, smart dilators, standard bite blocks, airway bite blocks and pipelines. Our obesity device is designed to perform incision-less and endoscopic bariatric surgery. Our gerd device is used to promote healing at the gastroesophageal junction to prevent acid reflux. Our barrett's excision device is supplied to assist in the diagnosis and treatment of barrett's esophagus. Our dilators are used when an endoscopy demonstrates the narrowing of the esophagus. Our bite block is used to protect the endoscope used in transoral gastrointestinal procedures. Our airway bite blocks are provided to assist patients with larger tongues or smaller throats, caused by obesity and in breathing during endoscopic procedures.
18 Products/Services (Click for related suppliers)
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| • Airways & Bite Blocks, Bite Guards and Blocks |
| • Automatic Surgical Stapler (FDA Code: GAG / 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. |
| • Bariatric Equipment |
| • Bite Block (FDA Code: JXL / 882.5070) A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions. |
| • Dilators |
| • Endoscopic Accessories, Bite Blocks |
| • Endoscopic Bite Blocks (FDA Code: MNK / 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. |
| • Esophageal Dilators (FDA Code: KNQ / 876.5365) An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive). |
| • Gastroesophageal Reflux Disease (Gerd) Endoscopic Suture/Plication System (FDA Code: ODE / 876.1500) |
| • Gastrointestinal Endoscopy |
| • Hernia Aid |
| • Hernia Repair Kits, Plugs |
| • Hernia Support (FDA Code: EXN / 876.5970) A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss. |
| • 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. |
| • Intraluminal Gastroplasty Devices |
| • Obesity/Slimming Equipment |
| • Scar Treatment Kits |
| • Tubal Ligation Kits |