Gynescope Monopolar Forceps and Electrodes

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K902658 ↗

FDA Product Code

KNF

Device Class

Class II

Regulation

21 CFR Part 884.4160

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Gynescope Laparoscopic Trocars and Sleeves

  Class II

  FDA 510(k) K902656 Active Cleared 29 Jun 1990

• Gynecological Instrumentation

  Class II

  FDA 510(k) K895225 Active Cleared 5 Mar 1990

• Ott Insufflation Filter Tubing

  Class II

  FDA 510(k) K900878 Active Cleared 7 May 1990

• Modified Metal Speculum & Special Bullet Forceps

  Class I

  FDA 510(k) K902019 Active Cleared 7 Jun 1990

• Wallace Intrauterine Insemination Catheter

  Class II

  FDA 510(k) K901530 Active Cleared 23 Jul 1990

• Croak Ovarian Biopsy Forcep

  Class I

  FDA 510(k) K902049 Active Cleared 7 Jun 1990

See all devices from Gynescope Corp. →

• What is the Gynoscope Monopolar Forceps and Electrodes used for?

  The Gynoscope Monopolar Forceps and Electrodes is designed for electrosurgical procedures in gynecological and obstetric applications, particularly during endoscopic surgeries. It combines forceps with monopolar electrodes to enable controlled tissue coagulation and cutting, reducing bleeding while providing precise surgical control.

• Is the Gynoscope Monopolar Forceps and Electrodes intended for single-use or reuse?

  This device is explicitly intended for single-use only in controlled clinical settings like operating rooms or procedural suites. It is supplied in sterile packaging to ensure safety and prevent cross-contamination, adhering to best practices for disposable medical instruments.

• How should the Gynoscope Monopolar Forceps and Electrodes be stored?

  The device must be stored in its original sterile packaging until use. Proper storage conditions include a clean, dry environment protected from extreme temperatures, moisture, and direct sunlight. Unopened packaging should be kept sealed to maintain sterility and functionality.

• What safety protocols must be followed when using this device?

  The Gynoscope Monopolar Forceps and Electrodes requires adherence to electrosurgical safety protocols, including proper grounding of the patient and ensuring adequate insulation to prevent unintended current dispersion. Always follow manufacturer guidelines for device setup, use, and disposal to minimize risks.

• Does this device have any MRI safety information?

  The manufacturer does not specify any MRI safety information for the Gynoscope Monopolar Forceps and Electrodes. If MRI procedures are planned post-surgery, consult the device documentation and follow radiology department protocols to avoid potential hazards.