5MM Disposable Suction-Irrigation Cannula

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

510(k) Number

K933790 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Hydro-Probe

  Class II

  FDA 510(k) K934157 Active Cleared 26 Jan 1994

• Sterile, Disposable Endoscopic Trumpet Valve

  Class II

  FDA 510(k) K934098 Active Cleared 16 Dec 1993

• Watts Rake with Leur Lock Port

  Class II

  FDA 510(k) K934153 Active Cleared 18 Mar 1994

• 5, 6, 7, 9, 10, 11&12mm Blunt-Tipped Trocar Obturators

  Class II

  FDA 510(k) K934511 Active Cleared 17 Feb 1994

• Phx Technologies Corp., Bowel Grasper Device

  Class II

  FDA 510(k) K934021 Active Cleared 17 Dec 1993

• Phx Technologies Corp. Bowel Grasper Device

  Class II

  FDA 510(k) K934026 Active Cleared 17 Dec 1993

See all devices from Phx Technologies Corp. →

• What types of procedures is this cannula designed to assist with, and how does it differ from standard suction tools?

  This 5mm Disposable Suction-Irrigation Cannula is specifically designed for endoscopic procedures in urological or gastrointestinal interventions. Unlike standard suction tools, it combines both suction and irrigation functions in one flexible tubular device, allowing clinicians to clear obstructions, flush debris, or maintain visibility during surgery—all while being compatible with standard endoscopic instruments.

• Is this cannula reusable, or is it meant for single-use only? How does that affect its sterility?

  The cannula is intended for single-use only and is supplied sterile in sealed packaging. This design eliminates the need for reprocessing, reducing infection risks and ensuring each patient receives a clean, uncontaminated device. The sterile packaging is specifically designed for one-time use per patient.

• What sizes or models are available, and how is it stored before use?

  This cannula is available in a single size: 5mm diameter. It is supplied in sealed, sterile packaging, ensuring sterility until the first use. The packaging is designed for single-patient use, so no additional storage precautions are required beyond keeping it in its original, unopened container until ready for use.

• How does the FDA classify this device, and what does that mean for its regulatory pathway?

  The 5mm Disposable Suction-Irrigation Cannula is classified as a Class II medical device under FDA regulations. It received a 510(k) clearance (K933790) with a Substantially Equivalent (SESE) determination, meaning it was found to be comparable to a legally marketed device already on the market. This classification and clearance indicate it has undergone FDA review for safety and effectiveness before commercial distribution.