Jarit Hulka Uterine Tenaculum Forceps

• • Terminated Z-1305-2014 FDA Class II ·initiated 3 Mar 2014 ·via K082349, on the same 510(k)

  Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K082349 ↗

FDA Product Code

HDC

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Jarit Endoscopes, 600-600; 600-630; 600-650; 680

  Class II

  FDA 510(k) K931878 Active Cleared 19 Aug 1993

• Cope Lung Forceps #305-218

  Class I

  FDA 510(k) K771624 Active Cleared 6 Sep 1977

• Jarit Surgical Instruments

  Class II

  FDA 510(k) K931959 Active Cleared 5 Oct 1993

• Jarit Recommended Sinus Instruments

  Class II

  FDA 510(k) K944670 Active Cleared 2 Feb 1995

• Leiningeo Aortic Punch #310-395 & 397

  Class I

  FDA 510(k) K771625 Active Cleared 12 Sep 1977

• Jarit Surgical Instruments Catalog 615-330, 615-331, 615-334, 615-335, 615-338, 615-339

  Class II

  FDA 510(k) K933728 Active Cleared 23 Feb 1994

See all devices from J. Jamner Surgical Instruments, Inc. →

• What is the Jarit Hulka Uterine Tenaculum Forceps used for?

  This device is designed for atraumatic manipulation and stabilization of the uterus during obstetric and gynecological procedures. Its dual features—a single-tooth hook on one arm and a 3.6 mm uterine sound probe on the other—enable precise positioning, making it ideal for surgeries such as tubal ligation, hysteroscopy, and laparoscopy. The ring-handled design with a ratchet closure ensures secure yet controlled engagement with uterine tissue.

• Is the Jarit Hulka Uterine Tenaculum Forceps reusable or single-use?

  The Jarit Hulka Uterine Tenaculum Forceps is supplied as a reusable stainless steel instrument. Its durable construction allows for repeated sterilization and use in surgical settings, including hospitals and surgery centers. Reusability is supported by its robust design and compliance with FDA 510(k) clearance for obstetrics/gynecology applications.

• What are the key dimensions of the Jarit Hulka Uterine Tenaculum Forceps?

  The device has an overall length of 278 mm and a working length of 121 mm, optimized for ergonomic handling and precise surgical access. The 3.6 mm diameter uterine sound probe on one arm and the single-tooth hook on the other ensure targeted stabilization without damaging uterine tissue. These specifications are tailored for atraumatic use in minimally invasive procedures.

• How is sterility maintained for reusable instruments like this?

  As a reusable instrument, sterility is maintained through autoclave sterilization (steam sterilization) or other validated medical-grade sterilization methods. The stainless steel construction resists corrosion and degradation, ensuring longevity and reliability across multiple sterilization cycles. Always follow manufacturer guidelines for cleaning, disinfection, and sterilization to prevent contamination and maintain device integrity.

• What regulatory pathway does the Jarit Hulka Uterine Tenaculum Forceps follow?

  The device is regulated under the FDA 510(k) clearance pathway, specifically classified under Obstetrics/Gynecology (product code HDC) and determined to be substantially equivalent to a predicate device. The clearance number is K082349, and it falls under the Obstetrics (OB) Advisory Committee review. This classification ensures compliance with U.S. medical device regulations for surgical instruments.