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EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XP190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-P190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree. BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

The EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-XP190, OLYMPUS BF-P190, and BF-XT190) and BRONCHOVIDEOSCOPE BF-H1100 and BF-1TH1100 are used for endoscopic diagnosis and treatment within the respiratory organs. These endoscopes consist of three parts: the control section, the insertion section, and the connector section.

The EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a video system center, light source, documentation equipment, monitor, endo therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

The EVIS EXERA III DUODENOSCOPE TJF-Q190V has been designed to be used with an video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. The TJF-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)." TJF-Q190V is also compatible with Olympus system "EVIS X1 Video System Center OLYMPUS CV-1500 (K222584)." The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (CCD) chip which delivers images. The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal. There is an instrument channel located inside of the flexible insertion section. EndoTherapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion section to elevate endo therapy accessories for endoscopic treatment. A sterile, single-use distal cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182, K202661 and K220587.

The Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q are intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope. The Single Use 2-Lumen Cannula V PR-V614M is intended to be used to inject contrast medium in the biliary or pancreatic duct in combination with an endoscope.

The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series is comprised of nine (9) sterile, single-use, cannulas designed to inject contrast medium in the biliary or pancreatic duct when used in conjunction with a compatible endoscope. Each device has two sections: the handle (proximal portion) and the insertion portion. The insertion portion is introduced into the biliary or pancreatic ducts through an endoscope. The distal end of the insertion portion is designed for smooth cannulation of the papilla of Vater or the minor papilla. All models are visible under fluoroscopy and feature a distal marking system. The Single Use Cannula V and the Single Use 2-Lumen Cannula V PR Series models are to be used with compatible endoscopes.

The Disposable Distal Attachment D-201 Series have been designed to be attached to the distal end of the endoscope to keep the suitable depth of endoscope's view field within the gastrointestinal tract.

The Disposable Distal Attachment D-201 Series is comprised of seven (7), sterile, single-use, distal attachments of varying diameters. Each distal attachment is a short transparent plastic tube which is attached to the distal end of an endoscope to facilitate observation of tissues during endoscopic procedures. A subset of the models includes a drainage side hole that allows egress of water and blood during use. The Disposable Distal Attachment D-201 Series is to be used with compatible endoscopes.

The Disposable Grasping Forceps FG-52D/54D are intended to be used to retrieve foreign bodies, calculus or tissue specimens from the tracheobronchial tree in combination with an endoscope.

The Disposable Grasping Forceps FG-52D/FG-54D are designed to retrieve foreign bodies, calculus, or tissue specimens endoscopically within the tracheobronchial tree when used in conjunction with a compatible endoscope. Each device is provided sterile and consists of a handle and an insertion portion. The handle (proximal portion) of the Disposable Grasping Forceps includes a ring which can be pushed or pulled to open or close the grasping portion of the device. The distal end of the insertion portion consists of the grasping portion of the device. The grasping portion, manufactured from stainless steel, is provided in two shapes: spiral basket type (model FG-52D) and three nail type (model FG-54D) and has limited contact with the patient. The user will select the device model depending on procedural needs.

The Single Use Retrieval Basket V FG-V421PR/FG-V422PR/FG-V431P/FG-V432P are intended to be used to retrieve stones from the biliary tract in combination with an endoscope.

The Single Use Retrieval Basket V Series is comprised of four (4), sterile, single-use, retrieval baskets designed to retrieve stones from the biliary tract. The retrieval baskets, manufactured from stainless steel, are provided as an 8-wire or 4-wire type. Each device has two sections: the handle and the insertion. The grip of the handle is used to control and operate the retrieval basket. The insertion, consisting of the sheath and the retrieval basket, is introduced into the biliary tract through an endoscope. The subject devices are intended to be used with Olympus endoscopes featuring a working length of less than 1400 mm (model: TJF) and a channel inner diameter of Ø 4.2 mm. The Olympus Lithotriptor (model BML-110A-1 or BML-610A) may be used in case of an emergency. Legally marketed Olympus guidewires (outer diameter Ø 0.89 mm) may be used with the Single Use Retrieval Basket V FG-V431P and FG-V432P models.

The Single Use Reloadable Clip Applicators HX-810 Series, Long Clip HX-610 Series, Short Clip HX-610 Series and Super Short Clip HX-610-135XS have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of: (1) Endoscopic marking, (2) Hemostasis for (a) Mucosal/sub-mucosal defects < 3 cm, (b) Bleeding ulcers, (c) Arteries < 2 mm, (d) Polyps < 1.5 cm in diameter, (e) Diverticula in the colon, (3) As a supplementary method, closure of Gl tract luminal perforations < 20 mm that can be treated conservatively.

The instruments (AKA EZClip) have been designed to be used with an Olympus endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of: (1) Endoscopic marking, (2) Hemostasis for (a) Mucosal/sub-mucosal defects < 3 cm, (b) Bleeding ulcers, (c) Arteries < 2 mm, (d) Polyps < 1.5 cm in diameter, (e) Diverticula in the colon, (3) As a supplementary method, closure of Gl tract luminal perforations < 20 mm that can be treatively. The Single Use Reloadable Clip Applicators and Clips are single-use devices. The HX-810 series Applicators are sterilized by Ethylene Oxide Gas and the HX-610 series Clips are sterilized by Gamma-ray radiation. The Single Use Reloadable Clip Applicators and Clips are used in a combined state. The clip connected to the hook portion of the applicator is controlled via operation wire by the slider. The clip protruded from the coil sheath opens to the maximum opening width when the slider of the applicator is pulled towards the operator. Clipping is achieved when the slider of the applicator is pulled completely and the clip connector is broken. Upon completion, the clip and the applicator are no longer connected. Once the clipping is performed, the closure force of clips remains in place until tissue necrosis occurs, and the clip is excreted naturally.

OES CYSTONEPHROFIBERSCOPEs OLYMPUS CYF-5 and CYF-5R have been designed to be used with an Olympus light source, documentation equipment, display monitor. EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.

The subject device consists of three parts: the control section, the insertion section, the eyepiece section. The basic principle including user interface and operation for the procedure of the subject device are identical to that of the predicate device.

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.

The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management. The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.

The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management. The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.