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Non-Shielded Surgical Trocar and Sleeve

FDA 510(k)

Class II (US FDA 510(k))

510(k) K963760

by Ethicon Endo-Surgery, Inc.

Identifiers

510(k) Number
K963760 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)

This device is a Non-Shielded Surgical Trocar and Sleeve, classified under FDA product code GCJ (876.1500) and intended for laparoscopic or endoscopic surgical procedures. It consists of an obturator sub-assembly with a flat blade and a sleeve sub-assembly with integral threads, designed to facilitate tissue penetration and instrument insertion during minimally invasive surgery.

The trocar is supplied as a reusable or single-use device (sterility status not specified in data) and is intended for use in controlled surgical environments such as operating rooms. It is not MRI-safe, and sizes or additional specifications are not detailed in the provided data. The device holds an FDA 510(k) clearance (K963760) under the Traditional review pathway, with a decision of Substantially Equivalent to the predicate.

Frequently asked questions

What types of surgical procedures is this trocar designed for, and how does it function during those procedures?

This Non-Shielded Surgical Trocar and Sleeve is designed for laparoscopic or endoscopic surgical procedures, which are minimally invasive techniques. The device consists of two main parts: an obturator with a flat blade and a threaded sleeve. The obturator helps penetrate tissue to create a pathway, while the sleeve remains in place to allow surgical instruments to be inserted and manipulated within the body. This setup is commonly used in procedures requiring controlled access, such as certain abdominal or pelvic surgeries.

Is this trocar reusable or single-use, and what does that mean for my surgical workflow?

The trocar is supplied as either a reusable or single-use device, though the sterility status isn’t specified in the data. If reusable, it would require cleaning, sterilization, and reprocessing between uses, which may involve additional time and resources in your operating room workflow. If single-use, it would be discarded after a single procedure, reducing the risk of cross-contamination but increasing waste management considerations. Check with your facility’s infection control protocols to determine the best approach for your setting.

What should I consider when storing this trocar, and are there any special handling instructions?

The data doesn’t specify storage conditions, but as a surgical instrument used in controlled environments like operating rooms, it should be stored in a clean, dry place away from direct sunlight or extreme temperatures. If reusable, follow your facility’s reprocessing guidelines to maintain sterility and functionality. For single-use devices, ensure proper packaging integrity until the time of use to preserve sterility and performance.

How do I know if this trocar is compatible with my existing surgical instruments, and are there different sizes available?

The provided data doesn’t detail specific sizes or compatibility with other instruments, so you’ll need to verify this with Ethicon Endo-Surgery or your surgical team. Since this trocar is designed for laparoscopic or endoscopic procedures, it should align with standard instrument diameters used in those settings. Always confirm sizing and compatibility before use to ensure smooth integration with your surgical tools.

What does the FDA clearance mean for this trocar, and how does it affect its use in clinical settings?

The trocar holds an FDA 510(k) clearance (K963760) under the Traditional review pathway, meaning it has been determined to be substantially equivalent to a predicate device already on the market. This clearance indicates that the device meets FDA standards for safety and effectiveness for its intended use in laparoscopic or endoscopic procedures. Clinically, this means it can be legally marketed and used in the U.S. for those specified surgical applications, but always follow your facility’s protocols and consult with your surgical team for proper implementation.

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: K963760 FDA 510(k) - NON-SHIELDED SURGICAL TROCAR AND SLEEVE, 510k.innolitics.com, Non-shielded Surgical Trocar And Sleeve 510 (k) FDA Premarket ..., Non-shielded Surgical Trocar and Sleeve - Beudamed

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) K963760 24 fields · synced Sep 19, 2026