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BASX Bladeless Trocar

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K062209

by Ethicon Endo-Surgery, LLC

Identifiers

510(k) Number
K062209 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 BASX Bladeless Trocar is a laparoscopic device classified under the nomenclature category for trocars, designed for creating access ports in minimally invasive surgical procedures. It features a bladeless design to reduce the risk of vascular or visceral injury during insertion, facilitating safer entry into the abdominal or pelvic cavities.

This trocar is intended for single-use in laparoscopic surgeries and is supplied sterile. It is regulated under FDA 510(k) clearance (K062209) and meets the requirements of the Medical Device Directive (MDD). Available in standard sizes for general surgical applications, it is designed for use in procedures requiring controlled access, such as gastrointestinal or urological interventions, and must be stored as directed to maintain sterility.

Frequently asked questions

What types of surgical procedures is the BASX Bladeless Trocar commonly used for, and why is its bladeless design important?

The BASX Bladeless Trocar is primarily used in laparoscopic surgeries requiring controlled access, such as certain gastrointestinal or urological procedures. Its bladeless design reduces the risk of accidental injury to blood vessels or internal organs during insertion, making it safer for creating access ports in the abdominal or pelvic cavities compared to traditional trocars with sharp blades.

Is the BASX Bladeless Trocar meant to be reused, or is it designed for single-use only? How should it be handled to maintain sterility?

The BASX Bladeless Trocar is explicitly designed for single-use only in laparoscopic surgeries. To maintain sterility, it is supplied sterile and must be stored according to the manufacturer’s instructions—typically in a sealed, sterile packaging—until immediately before use. Avoid opening or handling the device until the surgical procedure begins.

What sizes are available for the BASX Bladeless Trocar, and how do I determine the correct size for a patient?

The BASX Bladeless Trocar is available in standard sizes for general surgical applications, though the exact sizes aren’t specified in the data. Sizing depends on the surgical approach, port requirements, and the patient’s anatomy. Consult the manufacturer’s surgical guidelines or your facility’s protocol to select the appropriate size, as incorrect sizing may compromise access or safety during the procedure.

How is the regulatory status of this device defined, and what does the FDA 510(k) clearance (K062209) mean for its use?

The BASX Bladeless Trocar holds FDA 510(k) clearance (K062209) under the Traditional review pathway, meaning it was determined to be *substantially equivalent* to a legally marketed device already on the market. This clearance confirms it meets U.S. safety and performance requirements for its intended use in laparoscopic surgeries. Clinically, this means it’s authorized for single-use access in minimally invasive procedures as described, but always verify compliance with your facility’s protocols.

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: ENDOPATH BASX® Laparoscopic Trocars | Ethicon | J&J MedTech, BASX? BLADELESS TROCAR - Ethicon - PDF Catalogs - MedicalExpo, Single Basx Bladeless Trocar, BASX BLADELESS TROCAR (K062209) — FDA 510 (k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, LLC

Sources (2)

  • FDA 510(k) K062209 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026