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Modulap

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983623

by Atc Technologies, Inc.

Identifiers

510(k) Number
K983623 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Modulap Laparoscopic Irrigation/Aspiration Cannula is a reusable laparoscopic device designed for fluid management during minimally invasive surgical procedures. It features a 10mm diameter shaft with perforations, enabling simultaneous irrigation and aspiration to maintain clear visualisation and optimal operating conditions within the surgical field.

This device is intended for use in laparoscopic settings, supplied sterile or prepared for reuse as per manufacturer guidelines. It is classified under FDA product code GCJ, authorised via a Traditional 510(k) clearance (K983623) for Gastroenterology and Urology applications. Storage and reprocessing instructions must adhere to regulatory and facility protocols to ensure safety and functionality.

Frequently asked questions

What types of surgical procedures is the Modulap Laparoscopic Irrigation/Aspiration Cannula designed for, and how does it help during those procedures?

The Modulap is specifically designed for use in laparoscopic surgeries within gastroenterology and urology applications. Its 10mm perforated shaft allows simultaneous irrigation and aspiration, which helps maintain a clear surgical field by removing debris, blood, or excess fluid while delivering irrigation fluid—critical for visibility and precision during minimally invasive procedures.

Is the Modulap Laparoscopic Irrigation/Aspiration Cannula single-use or reusable, and what does that mean for my facility’s workflow?

The Modulap is reusable, meaning it can be sterilized and reused per the manufacturer’s guidelines. This reduces single-use costs and waste, but your facility must follow strict reprocessing protocols (including cleaning, sterilization, and inspection) to ensure safety and functionality before each use, as outlined in the device’s instructions.

How is the Modulap supplied, and do I need to perform any preparation before use?

The Modulap is supplied sterile or prepared for reuse—check the packaging or manufacturer’s instructions to confirm. If sterile, it’s ready for immediate use after opening. If reusable, it must undergo facility-specific reprocessing (cleaning, sterilization, and inspection) before use, as required by regulatory and institutional protocols to maintain sterility and performance.

What storage requirements should I follow for the Modulap to ensure it remains functional and safe for reuse?

The Modulap must be stored in a clean, dry environment following reprocessing if reusable, and protected from contamination or physical damage. If sterile, it should be stored according to the manufacturer’s instructions for sterile instruments—typically in a sealed, sterile barrier pouch or container until use. Always follow facility and regulatory guidelines to prevent degradation or compromise of sterility.

What does the FDA’s clearance for this device mean for my clinical or purchasing decisions?

The Modulap received FDA 510(k) clearance (K983623) under product code GCJ, which means it was determined to be substantially equivalent to a legally marketed device for gastroenterology and urology laparoscopic irrigation/aspiration. This clearance does not imply clinical superiority but confirms the device meets FDA safety and effectiveness standards for its intended use in minimally invasive procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Modulap 00817428020073 Medical Device Identification, Modulap Category | ATC Technologies, Inc. Medical Devices, Needle Tip Probe | ATC Technologies, Inc. Medical Devices, Modulap — FDA Class II Medical Device | MedEquip Directory, K983623 FDA 510 (k) - MODULAP | Atc Technologies, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atc Technologies, Inc.

Sources (1)

  • FDA 510(k) K983623 24 fields · synced Sep 19, 2026