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Endopath Tristar Dissector and Tissue Manipulator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K946241

by Ethicon Endo-Surgery, Inc.

Identifiers

510(k) Number
K946241 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 Endopath Tristar Dissector and Tissue Manipulator is a laparoscopic surgical instrument designed for dissection and manipulation of tissue during minimally invasive procedures. Classified under product code GCJ as a Laparoscope for general and plastic surgery, it facilitates precise tissue separation and handling within the abdominal or pelvic cavities.

This device is intended for single-use in controlled surgical environments and has received FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent. Supplied sterile, it is regulated under 21 CFR 876.1500 and is intended for use in laparoscopic procedures, adhering to standard surgical sterility and handling protocols.

Frequently asked questions

What types of laparoscopic procedures is the Endopath Tristar Dissector and Tissue Manipulator primarily used for?

The Endopath Tristar Dissector and Tissue Manipulator is designed for general and plastic surgery laparoscopic procedures, specifically to assist with dissection and tissue manipulation within the abdominal or pelvic cavities. Its precise design helps surgeons separate and handle tissues during minimally invasive surgeries, making it suitable for procedures where careful tissue control is required.

Is the Endopath Tristar Dissector and Tissue Manipulator intended for reuse, or is it meant to be used only once?

The Endopath Tristar Dissector and Tissue Manipulator is explicitly intended for single-use in controlled surgical environments. This ensures patient safety and sterility, aligning with standard surgical protocols for laparoscopic instruments.

How is the Endopath Tristar Dissector and Tissue Manipulator supplied, and what does that mean for surgical preparation?

The device is supplied sterile, meaning it is pre-sterilized by the manufacturer and ready for immediate use in the operating room. This eliminates the need for additional sterilization steps by the surgical team, streamlining workflow and ensuring compliance with surgical sterility standards.

What regulatory pathway was followed for FDA clearance of this device, and which committees were involved?

The Endopath Tristar Dissector and Tissue Manipulator received FDA clearance under the Traditional 510(k) pathway, determined to be Substantially Equivalent (SESE) to a predicate device. The review was conducted under the Gastroenterology and Urology (GU) advisory committee, reflecting its intended use in laparoscopic procedures for those specialties.

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 (R) Tristar (Tm) Dissector and Tissue Manipulator, ENDOPATH (R) TRISTAR (TM) DISSECTOR AND T... (K946241) - FDA 510 (k), Endopath (R) Tristar (Tm) Dissector and Tissue Manipulator, ENDOPATH (R) TRISTAR (TM) DISSECTOR AND TISSUE… - FDA.report, PDF K946241 - Endopath(R) Tristar(Tm) Dissector and Tissue Manipulator

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ethicon Endo-Surgery, Inc.

Sources (1)

  • FDA 510(k) K946241 24 fields · synced Sep 19, 2026