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The Reprocessed Hot Biopsy Forceps are intended to be used for endoscopic tissue sample acquisition, controlled coagulation/cautery, and sessile polyp removal in the gastrointestinal tract.

The device consists of a proximal handle containing an electrosurgical plug which is connected, via a coil, spring or rod mechanism, to the biopsy cup or alligator forceps at the distal tip. The biopsy forceps range from 160 to 240 cm in length and 2.2-2.5 mm in diameter. The jaws range from 2.2 to 2.5 mm in diameter. The cup forceps may or may not have serrated edges, a fenestration, needle, or distal biting tooth. The forceps are covered with a sheath of electrical insulation. The electrosurgical plug on the handle used for connection to the appropriate electrosurgical unit. This submission does not include the electrosurgical box that the forceps connect to or its associated connecting cable.

Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps are intended to be used during GI procedures for endoscopic tissue sample acquisition. Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract. Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.

Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by Clear Medical to Clear Medical protocol Number 40003. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. Clear Medical is a "third party reprocessor" and reprocesses used, single-use medical devices. Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps. CMI intends to reprocess used disposable hot and cold biopsy forceps manufactured by Micovasive. CMI reprocessed biopsy forceps are disposable unless reprocessed again by Clear Medical, Inc.

The MediSISS Reprocessed Hot Biopsy Forceps and accessories are intended to be used endoscopically to obtain tissue specimens, remove polyps, and cauterize tissue.

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When used with a compatible electrosurgical unit, endoscope and patient grounding pad, electric biopsy forceps are intended for electrocautery and removal of polyps and/or tissue within the gastrointestinal tract. The forceps are prescription devices intended for a single patient use only.

Biopsy forceps are devices used to collect tissue samples and/or remove polyps within the gastrointestinal tract via the operating channel of endoscopic instruments. Electric biopsy forceps include an electrocautery function when used with a compatible electrosurgical unit. The devices consist of flexible, electrically isolated sheaths with distal grasping cups that are controlled by a proximal handle. The forceps are guided by endoscopy through a biopsy channel with a minimum dimension of 2.8 mm. Monopolar electrocautery requires electrical connection of the forceps to a compatible electrosurgical unit and use of an appropriate patient grounding pad. Vanguard receives previously used electric biopsy forceps from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the forceps; and returns them to the healthcare facility.