HSV Laparoscopy Set

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

510(k) Number

K941541 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What types of surgical procedures is the HSV Laparoscopy Set primarily used for, and why is it considered suitable for minimally invasive surgery?

  The HSV Laparoscopy Set is designed for minimally invasive surgical procedures in the abdominal or pelvic cavities, supporting both diagnostic and therapeutic interventions. It is particularly suited for procedures in gastroenterology and urology, as indicated by its FDA 510(k) clearance under the Gastroenterology and Urology advisory committees. The set provides visual access, illumination, and instrumentation, enabling surgeons to perform procedures with smaller incisions compared to traditional open surgery, reducing patient trauma and recovery time.

• Is the HSV Laparoscopy Set intended for reuse, or is it meant to be used only once? How does this affect its use in a surgical setting?

  The HSV Laparoscopy Set is intended for single-use only in controlled surgical environments. This design ensures patient safety by eliminating the risk of cross-contamination or infection that could arise from reprocessing reusable instruments. Clinicians must adhere to single-use protocols, discarding the set after one procedure and using a new, sterile set for subsequent surgeries.

• What does it mean that the HSV Laparoscopy Set is supplied sterile, and how should it be stored to maintain sterility before use?

  Being supplied sterile, the HSV Laparoscopy Set is pre-packaged and processed to meet strict sterilization standards, ensuring it is free from harmful microorganisms before reaching the surgical environment. To maintain sterility before use, the set should be stored in its original, unopened packaging in a clean, dry area away from direct sunlight, extreme temperatures, or sources of contamination. The packaging should never be opened until immediately before the procedure.

• What regulatory pathway did the HSV Laparoscopy Set follow to gain FDA clearance, and what does this mean for its use in clinical settings?

  The HSV Laparoscopy Set received FDA 510(k) clearance (K941541) under the Substantially Equivalent (SESE) classification, meaning it was determined to be as safe and effective as a legally marketed device that served as its predicate. This clearance was granted after review by the Gastroenterology and Urology advisory committees, ensuring its compliance with regulatory standards for laparoscopic procedures. Clinicians can rely on this clearance as confirmation that the device meets FDA requirements for use in diagnostic and therapeutic interventions in accredited surgical settings.