Identifiers
- 510(k) Number
- K932995 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 Surgical Trocar and Cannula is a medical device designed for surgical access, facilitating minimally invasive procedures by creating a pathway through body tissues. It is part of the Kii Access Systems portfolio, which includes various tools for general, bariatric, colorectal, urologic, and gynecologic surgeries.
The device is supplied as a single-use item and is intended for use in surgical settings. It is not reusable and requires proper storage conditions. The device has received FDA 510(k) clearance, indicating it has been reviewed and deemed substantially equivalent to a legally marketed predicate device.
Frequently asked questions
What is the Surgical Trocar and Cannula used for?
It is designed to create a pathway through body tissues for surgical access, facilitating minimally invasive procedures in various specialties.
Is the Surgical Trocar and Cannula reusable?
No, the device is supplied as a single-use item and is intended for use only once in a surgical setting.
What is the regulatory status of this device?
The device has received FDA 510(k) clearance, indicating it has been reviewed and deemed substantially equivalent to a legally marketed predicate device.
What surgical specialties is this device intended for?
It is part of the Kii Access Systems portfolio, which includes tools for general, bariatric, colorectal, urologic, and gynecologic 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: Kii Access Systems - Applied Medical, Kii Optical Access System | Applied Medical, TROCAR CANNULA ASSEMBLY AND METHOD OF MANUFACTURE - Applied Medical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K932995 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources
Sources (1)
- FDA 510(k) K932995 24 fields · synced Sep 25, 2026