Weck Trocar

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K915378 ↗

FDA Product Code

HET

Device Class

Class II

Regulation

21 CFR Part 884.1720

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Farrior Oval Speculum

  Class I

  FDA 510(k) K772380 Active Cleared 17 Jan 1978

• Endoscopic Needlholder Cat. Number 114705

  Class II

  FDA 510(k) K911272 Active Cleared 2 Jul 1991

• Hooks #'s 7600, 7602, 7603, 7616

  Class I

  FDA 510(k) K791985 Active Cleared 4 Oct 1979

• Neivs Tracheotomy Retractor

  Class I

  FDA 510(k) K772378 Active Cleared 9 Mar 1978

• Hemoclip X-20 Automatic Hemoclip Ligating Applier

  Class II

  FDA 510(k) K844836 Active Cleared 23 Jan 1985

• Weck Tying Forcep, Straight Titanium

  Class I

  FDA 510(k) K761251 Active Cleared 16 Dec 1976

See all devices from Edward Weck, Inc. →

• What types of surgical procedures is the Weck Trocar designed for, and why is it particularly useful in those settings?

  The Weck Trocar is specifically designed for laparoscopic procedures in obstetrics and gynecology, where controlled entry into the abdominal or pelvic cavity is required. It minimizes tissue trauma during insertion, making it ideal for minimally invasive surgeries such as hysterectomies, ovarian cyst removals, or other gynecologic interventions where precision and reduced patient discomfort are critical.

• Is the Weck Trocar intended for reuse, or is it meant to be used only once per patient?

  The Weck Trocar is explicitly designed for single-use only in controlled surgical environments. This ensures patient safety by eliminating the risk of cross-contamination or device degradation from repeated sterilization cycles, which is standard practice for disposable surgical instruments.

• How is the Weck Trocar supplied, and what should clinicians check before using it?

  The Weck Trocar is supplied sterile and ready for immediate use in surgical settings. Clinicians should verify the sterility seal is intact and confirm the correct size/model matches their laparoscopic system requirements, as the device comes in multiple configurations for compatibility with various instruments.

• What regulatory pathway does the Weck Trocar follow, and how does this affect its use in clinical settings?

  The Weck Trocar follows the FDA 510(k) clearance pathway, classified as a Class II medical device under the regulatory category for Laparoscopes (Gynecologic and Accessories). This means it has been determined *substantially equivalent* to a predicate device and adheres to FDA standards for surgical access tools, ensuring compliance with U.S. medical device regulations for obstetrics/gynecology procedures.