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The MyoSure™ Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

The modified MyoSure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate MyoSure System: - MyoSure Control Unit O - MyoSure Tissue Removal Device o - MyoSure Foot Pedal o The MyoSure Control Unit contains an electric motor and software controller that drives the MyoSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the MyoSure Foot Pedal. The MyoSURE Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The MyoSure Tissue Removal Device features a rotating/reciprocating (2.5 mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). The morcellator's cutter-blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the MyoSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The MyoSure Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.