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The IRIS Thermocoagulator and Digital Colposcope is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe, and to provide magnified visualization of the tissues of the vagina, cervix and external genitalia in order to aid in selecting areas for biopsy and diagnosing as needed for a colposcopy exam.

The Liger Medical IRIS Thermocoagulator and Digital Colposcope is a portable thermal coagulator with integral colposcope that provides assistance for clinician examination of the cervix as well as utilizes a heated probe to ablate human tissue. It is specifically designed for use in resource-limited settings. The colposcope and thermal ablation modes can be used separately from each other. The device is a handheld, portable, battery-operated, ablator with an LCD display and optical camera to assist diagnosis and treatment, in a safe, effective, easy to use package with sufficient battery life to sustain work for 4 hours. Thermal coagulation can be used in hospital and non-hospital professional healthcare locations. The IRIS colposcope/thermal ablation device is not intended on into the vaginal canal during colposcopic examination. The camera remains outside the vaginal cavity and functions comparably to a standard non-invasive colposcope in terms of providing magnified visual assistance to the clinician. There is no patient contact during the colposcopic examination. Contact between the clinician and the device is mitigated through good clinical practice of wearing protective gloves, limiting contact to intact skin protected by operating gloves. The thermal ablation probe, which is reusable and provided non-sterile, is designed to perform low-power destruction of human tissue with high temperatures by tissue contact with an electrically heated probe tip. The biocompatibility of the probe materials conforms to all recommended endpoints per FDA's guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for limited duration mucosal membrane contact.

The Liger Medical HTU-110 is intended for the destruction of human tissue with high temperatures by tissue contact with an electrically heated probe.

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The FMwand Ferromagnetic Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open, transabdominal only).

The FMwand Ferromagnetic Surgical System is a soft tissue cutting and coagulation device that consists of the FMwand Generator that is electrically connected to the sterile, single-use FMwand Handpiece by the FMwand Power Module (a resterilizable, reusable accessory cable) and a single-use, sterile air line. Like the predicate device, the handpiece includes actuation buttons that can be used to activate the handpiece tip. Also like the predicate device, an optional footpedal can be used to activate the handpiece. The connectors at both ends of the FMwand Power Module are designed to fit only the FMwand Generator and FMwand sterile, disposable accessories. The FMwand Power Module is provided non-sterile. It is intended to be cleaned and sterilized prior to the initial use and before each subsequent reuse.

The Domain Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open transabdominal only).

An electrosurgical cutting and coagulation device (and accessories) is a device intended to remove tissue and control bleeding by use of high-frequency electrical current (21 CFR §878.4400). It is classified as a Class II (510(k)) device. The Domain Surgical System is a soft tissue cutting and coagulation device that consists of a generator that is electrically connected to a sterile, single-use handpiece and an optional footswitch. Like the predicate devices, the handpiece includes an actuation button that can be used to activate heating in the handpiece tip. Also like the predicate devices, an optional footswitch can be used to activate the system.

Endocervical Hysterectomy Electrode is indicated for treatment of following Condition 1. Excision of inner cervix during supracervical hysterectomy.

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The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias.

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To be used for soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.

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Indication for the LLETZ procedure include: A cytological and coposcopic suspicion of CIN; A transformation zone which is fully visible and fully confined to the cervix; LLETZ in indicated for those patients who have had abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix unsatisfactory finding and who, in the physician's opinion are suitable candidates for the procedure.

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