Uterine Tenaculum

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Uterine Tentaculum

510(k) Number

K890379 ↗

FDA Product Code

HDC

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Intestinal Crushing Clamp

  Class I

  FDA 510(k) K890371 Active Cleared 3 Feb 1989

• Septum Elevator

  Class I

  FDA 510(k) K890365 Active Cleared 3 Feb 1989

• Intestinal Clamp

  Class I

  FDA 510(k) K890372 Active Cleared 3 Feb 1989

• Cervical Biopsy Forceps

  Class I

  FDA 510(k) K890380 Active Cleared 27 Feb 1989

• Uterine Dressing Forceps

  Class II

  FDA 510(k) K890378 Active Cleared 13 Feb 1989

• Artery Forceps

  Class I

  FDA 510(k) K890246 Active Cleared 27 Jan 1989

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• What is the primary use of the Uterine Tenaculum in surgical procedures?

  The Uterine Tenaculum is designed specifically for obstetrics and gynecology to grasp, hold, or manipulate tissues such as the cervix or uterine walls. Its main purpose is to provide stable traction or countertraction during surgical interventions, ensuring precise access, dissection, or stabilization within the uterine cavity or cervix. This is particularly useful in procedures requiring controlled tissue manipulation.

• Is the Uterine Tenaculum intended for single-use or reusable applications?

  The Uterine Tenaculum is supplied as a reusable surgical instrument. It is intended to be sterilized and reused following standard medical device sterilization protocols, ensuring compliance with clinical hygiene standards. Reusability is common for surgical instruments to balance cost-effectiveness and infection control.

• What regulatory classification and approval does the Uterine Tenaculum hold?

  The Uterine Tenaculum is classified under FDA product code HDC and falls under Class II regulatory classification with special controls. It has been granted 510(k) clearance by the FDA, meaning it has been determined to be substantially equivalent to a legally marketed device. This classification ensures it meets specific safety and performance standards for obstetrics/gynecology instruments.

• How should the Uterine Tenaculum be stored to maintain its functionality?

  The Uterine Tenaculum should be stored following general surgical instrument guidelines to preserve sterility and functionality. This typically involves keeping it in a clean, dry environment, protected from moisture, dust, and physical damage. Proper storage ensures the instrument remains ready for use when needed while maintaining its integrity for repeated sterilization cycles.

• Are there any specific safety considerations mentioned for the Uterine Tenaculum?

  The available data does not specify any unique MRI safety considerations or restrictions for the Uterine Tenaculum. However, as with all surgical instruments, it should be used in controlled clinical settings where proper training and adherence to sterile techniques are maintained. Always follow manufacturer guidelines and institutional protocols for safe and effective use.