(171 days)
Providing thorough irrigation and aspiration of the peritoneal cavity.Bleeders can be identified,bile,stones,tissue,blood & smoke from cautery procedures can be aspirated leaving the abdominal cavity clean and dry.
Sole purpose of these instruments are to move tissue around. Sole purpose of these instrain by means of grasping any body They can not grasp or restrain by addints the body cavity They can not grasp of resorain by de into the body cavity organ or tissue. They are introduced they can only move through a brood trough the or up and down.
Devices which create portals into an operative site enableing the introduction thru said devices, tools for the direct the introduction and/or dissecting, cutting, repairing, removal observation and/or internal tissues and/or organs.
Devices that pass thru portals into a periteal cavity allowing direct or indirect visualization by means of a camera thru said direct of internal tissues or organs may be visualized for either diagnostic or operative procedures.
Verres needles puncture through the abdominal wall to enable verres needies puncture theabdominal cavity creating space the introduction of gacce insternal body organs, allowing for the sa between the rabora and the scopic instrumentation into the peritoneal cavity.
Instruments which permit suturing internal tissues or organs thru cannula portals by pushing suture knots down to the tissue site being repaired.
Instruments which permit the grasping and manipulation of the country the countancel covity enableing a surgeon Instruments which the pritoneal cavity enableing a surgeon needles inside the peritoneal cavity enableing a surgeon needles inside the periconeal cavily charoscopic procedures.
Instruments insulated for cautery or non-insulated for non-cautery procedures which enable a surgeon to grasp, biopsy,cut,coagulate,manipulate or retrieve internal biopby, a your while performing laparoscopic procedures.
Trocar and Trocar Sleeves, Laparoscopes, Laparoscopic Forceps and Laparoscopic Instruments, FAN RETRACTORS AND FINGER DISSECTORS, TROCARS, TROCAR SLEEVES AND DILATORS, VERRES NEEDLES, KNOT PUSHER, NEEDLE HOLDERS, MONOPOLAR ELECTRODES,CAUTERY FORCERS,BIPOLAR FORCEPS & SCISSORS AND NON-CAUTERY FORCEPS
This document is a 510(k) premarket notification from the FDA for various laparoscopic instruments manufactured by Jakoubek Medizintechnik GmbH. The document is primarily focused on establishing substantial equivalence to existing devices and outlines the indications for use of several instruments. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information.
§ 876.1500 Endoscope and accessories.
(a)
Identification. 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.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.