VersaOne Bladeless Trocar
FDA 510(k)Class II (US FDA 510(k))
by Covidien
Identifiers
- 510(k) Number
- K162584 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 VersaOne Bladeless Trocar is a surgical instrument classified as a bladeless trocar (Product Code: GCJ), designed to create and maintain a controlled entry port for endoscopic procedures. It eliminates the need for a sharp blade while providing secure access for laparoscopic instruments, reducing tissue trauma and improving procedural safety.
This device is intended for use in endoscopic surgeries, including gynecologic, general, thoracic, and urologic procedures, and is supplied as a reusable instrument. It features a fixation cannula and is available in a standard length of 5 mm (e.g., NONB5STF), with additional sizes like 15 mm (e.g., NB15STF) also referenced. The device holds FDA 510(k) clearance (K162584) and is distributed in sterile packaging for single-use applications, though reuse may be permitted under specific conditions as per manufacturer guidelines.
Frequently asked questions
What types of surgical procedures is the VersaOne Bladeless Trocar intended for, and how does it differ from traditional trocars?
The VersaOne Bladeless Trocar is designed for endoscopic surgeries across multiple specialties, including gynecologic, general, thoracic, and urologic procedures. Unlike traditional trocars that use a sharp blade to penetrate tissue, this device creates a controlled entry port without a blade, reducing tissue trauma and improving procedural safety. Its bladeless design aims to minimize injury while maintaining secure access for laparoscopic instruments.
Is the VersaOne Bladeless Trocar intended for single-use or reusable applications, and what sizes are available?
The VersaOne Bladeless Trocar is supplied in sterile packaging for single-use applications, though reuse may be permitted under specific conditions as outlined by the manufacturer. Available sizes include a standard 5 mm length (e.g., NONB5STF) and a larger 15 mm length (e.g., NB15STF), both featuring a fixation cannula for secure instrument access.
How is the VersaOne Bladeless Trocar different from other trocars in terms of regulatory clearance?
The VersaOne Bladeless Trocar holds FDA 510(k) clearance (K162584) under a special review process, classified under Product Code GCJ. This clearance indicates it is considered substantially equivalent to a legally marketed predicate device, meaning it meets regulatory standards for safety and effectiveness as determined by the FDA’s review of its design and intended use.
What special features does the VersaOne Bladeless Trocar include to enhance safety during endoscopic procedures?
The VersaOne Bladeless Trocar eliminates the need for a sharp blade, which reduces the risk of tissue trauma and accidental injury during insertion. It includes a fixation cannula to maintain a stable entry port for laparoscopic instruments, ensuring secure access while minimizing complications during procedures like gynecologic, thoracic, or urologic surgeries.
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: VersaOne™ bladeless trocar - Medtronic, VersaOne™ optical trocar - Medtronic, NONB5STF - Covidien VersaOne™ Bladeless Trocar with ... - SurgiShop, VersaOne Trocars: Access System by Medtronic - CIA Medical, Covidien Versaone Bladeless Optical Trocar - 5mm X 70mm - XS Supply
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162584 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien
Sources (1)
- FDA 510(k) K162584 24 fields · synced Sep 19, 2026