Search Results

The Midfield Light Pipe is a disposable microsurgical instrument used to conduct a field of light to the posterior seqment of the eye in order to visualize the internal structures of the eyes during ophthalmic surgery.

The Midfield Light Pipe will be offered in a 23 gauge (GA), 25GA and 27GA size. Each device consists of an ABS handpiece, 304 stainless steel illumination connector, LDPE EVA jacket material, PMMA illumination fiber, 304 stainless steel needle and a PMMA scleral depressor. The Midfield Light Pipe is an external communicating device, in contact with tissue/bone/dentin for a limited duration (<24 hours). The device will be identical to the existing Peregrine 23GA and 25GA Chandelier Illuminator (K151604), except the illumination fiber used in the Midfield will have a higher numerical aperture (NA). The higher NA of the fiber will allow for a wider light field for improved visibility for the surgeon, without compromising illumination intensity ("brightness"). Peregrine will also provide a scleral depressor for use with the Midfield Light Pipe. Transcleral illumination makes use of the scleral depressor for examination of the vitreous base by manipulating and indenting the sclera while illuminating through the sclera. The scleral depressor is only intended to contact the outer surface of the eye (sclera) for a limited duration (<24 hours). The Midfield Light Pipes are comprised of common materials used in ophthalmic devices. The light pipe is mechanical and contains no electrical components. The Midfield Light Pipes only transmit light energy, they do not control the intensity of the light output - this is controlled by the operating system to which it is attached.

The Hawkeye Control Unit with Eyas Endoscope is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision.

The E Surgical Hawkeye Control Unit with Eyas Endoscope is an arthroscope system, consisting of the Hawkeye Control Unit (Medical Tablet plus Console Box), and the Eyas Endoscope. The Medical Tablet is a touch panel computer for the system function control, endoscope image displays and operation data storage. The Eyas Endoscope is a hand-held, single-use device for accessing the interior of a joint to capture the real-time image of the target site through a small incision. The Console Box is an interface between the Medical Tablet and Eyas Endoscope. There are 10 models of Eyas Endoscope in this system; including 2 different directions of view (0° and 30°) in combination with 5 different working lengths. All these models must be used in conjunction with Hawkeye Control Unit to perform as intended. The E Surgical Hawkeye Control Unit with Eyas Endoscope is also capable recording and storing the images in the system for later review.

The Eblator Device is intended for general arthroscopic applications, which include cutting, vaporization, and coagulation. This device is intended to be used in conjunction with a general purpose electrosurgical generator via a standard active lead and a standard return lead connection. The device is only operable when activated in an appropriate conductive media, such as a standard saline solution.

The application device, the Eblator Device, is an electrosurgical ablator for general arthroscopic applications. In conjunction with a general purpose electrosurgical generator, the Eblator Device provides cutting, vaporization and coagulation of target tissue by radio frequency electrosurgical energy. As with most hand-controlled surgical pencils, the Eblator Device can also be used with footswitch control when a footswitch is connected to a generator designed for footswitch control. The Eblator Device is requesting clearance for 4 models of Eblator Device, representing different combinations of electrode configurations and aspiration design. The Eblator Device models include 2 different electrode angles, 90° and 50°, as well as with or without aspiration design. Except for these characteristics, these 4 models are all identical. The Eblator Device is designed to be used with a compatible electrosurgical generator and aspiration system (aspiration model only). These devices are single use and are sold sterile.

A Single use, non sterile dispersive electrode with or without a pre-attached cord to adhere to the infant patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

The E Surgical Infant Patient Return Electrode Dual Plate is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electro surgery between the generator, the active electrode, and an infant patient.

E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

The E Surgical coated electrodes are designed as a standard stainless steel active electrode with a nonstick coating to prevent tissue and char build-up on the electrode. Three models: ball, needle, and blade are included.

A single use, non-sterile dispersive electrode with or without a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

The E Surgical Patient Return Electrode Dual Plate is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electrosurgery between the generator, the active electrode, and an adult patient.