Endopath Xcel Bladeless Trocar with Optiview Technology
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122511 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 Xcel Bladeless Trocar with Optiview Technology is a surgical trocar designed for minimally invasive procedures. It features a blunt tip and Optiview technology, which provides visual confirmation of trocar placement to enhance safety during laparoscopic or endoscopic surgeries.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510K clearance (K122511) and MDR, with a product code of GCJ. The trocar is intended for use in settings such as gastrointestinal and urological procedures, adhering to standard surgical sterility and safety protocols.
Frequently asked questions
What types of procedures is the Endopath Xcel Bladeless Trocar with Optiview Technology primarily used for?
This trocar is designed for minimally invasive laparoscopic or endoscopic surgeries, particularly in gastrointestinal and urological procedures. The Optiview Technology provides visual confirmation of placement, which enhances safety during these delicate operations.
How is the Endopath Xcel Bladeless Trocar with Optiview Technology supplied, and is it reusable?
The trocar is supplied sterile and is intended for single-use only, meaning it should not be reused after a single surgical procedure. This aligns with standard surgical sterility protocols to ensure patient safety.
What regulatory pathways does the Endopath Xcel Bladeless Trocar follow, and how was its equivalence determined?
The device follows FDA 510K clearance (K122511) and MDR (Medical Device Regulation) pathways. Its equivalence was determined through a traditional 510(k) review, where it was classified as Substantially Equivalent (SESE) by the Gastroenterology and Urology advisory committees.
Does the Optiview Technology serve any specific purpose in the trocar’s design, and how does it improve safety?
Yes, the Optiview Technology provides visual confirmation of trocar placement during surgery. This feature helps surgeons verify correct positioning before proceeding, reducing the risk of complications like organ perforation or unintended tissue damage.
What should I consider when storing the Endopath Xcel Bladeless Trocar with Optiview Technology?
Since the trocar is sterile and single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines to maintain sterility until use.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K122511 | Class II | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
Sources (2)
- FDA 510(k) K122511 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026