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The Senhance™ Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.

The Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapter are intended as additions to the suite of monopolar hook instruments and adapters previously cleared for use with the TransEnterix Senhance™ Surgical System. Three monopolar electrodes and one monopolar electrode adapter are being added. The instruments and adapter are modifications of the predicate TransEnterix® Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapters FDA cleared through K181517 (October 9, 2018). Like the predicate devices, the subject devices are multi-use surgical devices that are cleaned and steam sterilized by the end user before the first use and after each use.

The InSure® ONE™ is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. The InSure® ONE™ test is used to aid in the detection of lower gastrointestinal bleeding.

The InSure® ONE™ – One Day Fecal Immunochemical Test qualitatively detects human hemoglobin from blood in fecal samples. The fecal sample is generally collected by the test subject at home. Toilet bowl water samples are taken using long handled brushes to collect a small volume of water from around the defecated stool. The toilet water test sample once collected is placed on an InSure ONE Test Card. The InSure ONE Test Card then serves as a means to transport the dried samples to the laboratory. The InSure ONE test detects human hemoglobin in toilet bowl water. The test is developed in the laboratory or medical professional office with appropriate quality control. The FOBT Controls (K101831) are recommended for use as external controls. Components of InSure® ONE™ - One Day Fecal Immunochemical Test: - a. The InSure® ONE™ Collection Kit* contains: - InSure® ONE™ Instructions for Use-Patient ● - InSure® ONE™ Test Card ● - Brush Kit containing 2x brushes and a waste bag ● - Business reply form and envelope ● - b. The InSure® ONE™ or InSure® FIT Developer Kit* (for development and interpretation of the test) contains: - InSure® ONE™ Instructions for Use-Professional Laboratory . - InSure® ONETM Test Strips: The Test Strips contain mouse monoclonal anti-. human hemoglobin test line antibodies and a conjugate-specific polyclonal (donkey anti-goat) antibody control line, and a conjugate of anti-human hemoglobin polyclonal (goat) antibodies bound to colored (colloidal gold) particles. - . InSure® ONE™ Run Buffer: Contains borate salts, ethanol, bovine serum albumin, and sodium azide as preservative. - c. The InSure® ONE™ or InSure® FIT FOBT Controls contains: - · Instructions for Use - · Positive Control - · Negative Control *The above kits and components are supplied in a variety of packaging configurations and sold in combination or separately to meet customer requirements.

InSure® II FIT is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. Fecal immunochemical tests are useful screening aids for detecting primarily lower gastrointestinal (g.i.) disorders that may be related to iron deficiency an onemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. Health professionals recommend InSure II for use as part of routine physical examinations and in screening for colorectal cancer or other sources of of our g.i. bleeding.

InSure® II fecal immunochemical test (FIT)