Cabot Medical Niagara(Tm) 3.0 Liter High Flow Irri

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

510(k) Number

K924530 ↗

FDA Product Code

HET

Device Class

Class II

Regulation

21 CFR Part 884.1720

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Cabot Medical Optima Hand Instruments

  Class II

  FDA 510(k) K932977 Active Cleared 7 Sep 1993

• Cabot Medical Surgiflex(R) Suction-Irrigation Prob

  Class II

  FDA 510(k) K932626 Active Cleared 8 Jun 1994

• Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic Sheaths

  Class II

  FDA 510(k) K951972 Active Cleared 21 Jul 1995

• Cabot Disposable 10mm Suction Device

  Class II

  FDA 510(k) K924048 Active Cleared 22 Jan 1993

• Pleatman Sac Specimen Container

  Class II

  FDA 510(k) K923945 Active Cleared 5 Feb 1993

• Corson and Nezhat Suction/Irrigation Probes

  Class II

  FDA 510(k) K935786 Active Cleared 19 May 1994

See all devices from Cabot Medical Corp. →

• What is the Cabot Niagara 3.0L High-Flow Irrigation System used for?

  The Cabot Niagara 3.0L High-Flow Irrigation System is designed specifically for gynecologic and obstetric surgical procedures. It provides a controlled, high-volume fluid stream to maintain clear visibility and effective irrigation during laparoscopic and hysteroscopic interventions. This reduces the need for manual irrigation, helping surgeons perform procedures more efficiently and with better precision.

• How is the Cabot Niagara 3.0L High-Flow Irrigation System supplied and what are its sterility and usage requirements?

  The system is supplied as a single-use, sterile irrigation device, ensuring it meets surgical sterility standards for sterile environments. Due to its single-use nature, it must be handled according to standard surgical protocols to maintain sterility. It is not intended for reuse and should only be used once per procedure.

• Is the Cabot Niagara 3.0L High-Flow Irrigation System compatible with MRI machines?

  No, the Cabot Niagara 3.0L High-Flow Irrigation System is explicitly stated as not MRI-compatible. This means it should not be used in or near MRI equipment, as it could interfere with imaging or pose safety risks.

• What storage conditions are required for the Cabot Niagara 3.0L High-Flow Irrigation System?

  To preserve sterility and functionality, the system must be stored in a clean, dry environment. Proper storage conditions are critical to ensure the device remains uncontaminated and ready for use when needed. Avoid exposure to moisture, extreme temperatures, or direct sunlight.

• What regulatory clearance does the Cabot Niagara 3.0L High-Flow Irrigation System hold?

  The device holds FDA 510(k) clearance under the classification of gynecologic laparoscopes and accessories. This clearance confirms that the system meets U.S. medical device standards for high-flow irrigation in gynecologic and obstetric surgeries, as determined by the FDA’s 510(k) pathway.