Multaport Cannula Reducer and Accessories

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K981941 ↗

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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See all devices from Dexide, Inc. →

• What types of surgical procedures is this device primarily used for, and why is it designed this way?

  This device is primarily used in gastroenterology and urology procedures, particularly for minimally invasive surgeries requiring multiple instrument insertions into the abdominal cavity. The Multaport Cannula Reducer and Accessories is designed as a reusable laparoscopic system to create a secure entry point, allowing multiple instruments to be inserted through a single port. This reduces the number of external incisions needed, minimizing trauma and improving surgical efficiency for these specialized fields.

• Is this device single-use or reusable, and what steps must be taken to maintain it between uses?

  This device is reusable and supplied as a kit. Since it is intended for sterile surgical settings, the reusable components must be properly cleaned and sterilized between uses to ensure safety and functionality. The manufacturer’s instructions should be followed to maintain compliance with FDA’s special regulation 876.1500 for laparoscopic instruments, which governs the reprocessing of reusable surgical devices.

• How is this device different from standard laparoscopic cannulas, and what advantages does it offer?

  Unlike standard laparoscopic cannulas, which typically allow a single instrument at a time, the Multaport Cannula Reducer and Accessories includes a reducer and associated seals to enable multiple instruments to be inserted simultaneously through a single port. This design reduces the need for additional trocars, potentially lowering surgical site trauma and improving workflow in procedures where multiple tools (e.g., cameras, graspers, or biopsy tools) are required in gastroenterology or urology.

• What regulatory pathway was followed for this device’s approval, and what does that mean for clinicians?

  This device followed the FDA 510(k) clearance process, specifically under product code GCJ (Gastroenterology/Urology) and with a Traditional 510(k) review. The clearance (K981941) was granted in 1998 after demonstrating substantial equivalence to a legally marketed predicate device. For clinicians, this means the device meets FDA standards for safety and effectiveness in its intended laparoscopic applications, though adherence to sterilization and reprocessing protocols remains critical for reuse.